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Single Use Medical Examination Gloves Single Use Instruments Absorbents Wipes Woundcare Disposable Gloves Patient Identification First Aid Cotton Wool Personal Care Continence Care
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Page 1: Single Use Medical Examination Gloves · Vinyl is a synthetic polymer, more commonly known as polyvinyl chloride (PVC). To make the rigid polymer flexible and suitable for use as

Single Use Medical Examination Gloves

Single Use Instruments

Absorbents

Wipes

Woundcare

Disposable Gloves

Patient Identification

First Aid

Cotton Wool

Personal Care

Continence Care

Page 2: Single Use Medical Examination Gloves · Vinyl is a synthetic polymer, more commonly known as polyvinyl chloride (PVC). To make the rigid polymer flexible and suitable for use as

Contents

Contents

AQL1.5

EN 374-2

Level 2

EN 374-3

ASTMD6978-05

ASTMF1671

ASTMF1342

Product has been testedfor permeation bychemotherapy drugs

Product has been testedfor viral penetration

Product has been punctureresistance tested

Product is manufactured andinspected to AQL 1.5 (max 1.5%defects in any production batch)

Product conforms toEN 374-2 Level 2 (AQL 1.5)

Product has low chemicalresistance as defined byEN 374-3. Refer to manufacturerfor more details

Product is a medical device

Product is certified to thePPE Directive, as a Categorylll complex design device

For single use only

Product and packaging arefree from natural rubber latex

Explanation of Icons Used in this Catalogue

Introduction• About Robinson Healthcare 1• Readigloves® – Providing Protection for People 2• Readigloves® – Legislation & Standards 4• Choosing the Right Glove – The Facts! 8• Readigloves® – Advice on Use 12

Nytraguard® Nitrile Gloves Range• Nytraguard® Bluple® 14• Nytraguard® SkyBlue 16• Nytraguard® Tough 17• Nytraguard® ChemoPure® 18

Cyraguard® Latex Gloves Range• Cyraguard® Premium 21• Cyraguard® Essentials 22

Vinoguard® Vinyl Gloves Range• Vinoguard® Synthetic 24• Vinoguard® Premium 25

• Vinoguard® Essentials 26

• Glove Sample Service 27• Glove Size Guide 28

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About Robinson Healthcare

Robinson Healthcare has an established reputation as one of the leading manufacturers ofhealthcare products in the UK, providing medical professionals with products they can trust.

Leader of InnovationFounded in 1839, Robinson Healthcare has over 170 yearsexperience of working in partnership with healthcareprofessionals. Innovation remains central to the company’sproduct development plans. The introduction of Readigloves®follows the same philosophy, with innovative products andmanufacturing techniques that set Readigloves® apart fromthe rest.

UK Manufacturing FacilityThe majority of Robinson Healthcare products are produced ina UK manufacturing facility near Worksop in Nottinghamshire.The company operates a large Class 7 cleanroom with sterilepackaging facilities, two large autoclaves for product sterilisationand on-site laboratories to support product development,production and continued compliance with standards.

The new range of medical examination gloves is manufacturedby partner companies in Malaysia – the global centre of glovemanufacturing – to Robinson Healthcare’s own rigorousspecification. Every batch of products undergoes full qualityinspection by Robinson Healthcare’s own locally based QA staffbefore leaving the factory.

Full Compliance with Legislation and StandardsCompliance with legislation and standards is fundamental toRobinson Healthcare’s philosophy. In addition to certificates ofconformance for a wide range of medical devices, the companyhas certificates of compliance to a number of other importantstandards:

• BS EN ISO 9001:2008 – Quality Management System

• BS EN ISO 13485:2003 – Medical Devices Quality Management System

• BS EN ISO 14001:2004 – Environmental Management System

• MDD (Medical Devices Directive) – Annex V Certification

• BRC (British Retail Consortium) – Global Standard for Consumer Products

Understanding Customers NeedsRobinson Healthcare fully understands that a consistent andreliable supply chain is critical to the smooth running ofhealthcare services, pharmacy and retail operations. Extensivestocks of finished goods and raw material underpin thecompany’s supply from stock philosophy, maintaining a world-class level of service.

Investing for the Future – E-CommerceToday, many customers have already adopted electronic tradingwith Robinson Healthcare. The company has now committedsignificant investment in e-commerce to support new andexisting business via online trading to all market sectors.

The Robinson Healthcare website now offers the followingservices to all customers:

• Streamlined order processing, incurring virtually zero transactional costs

• 24 hour online ordering, via account or electronic payment

• Live stock enquiries and allocation

• Full trading history

• Order templates for regularly ordered baskets of product

Core Values and AimsRobinson Healthcare is committed to meeting customers’needs. To do so, it has adopted a number of core aims andvalues that are fundamental to the business:

• Create and maintain partnerships with customers to develop open, long term relationships

• Have a straightforward and honest approach to business

• Continued investment in research and development

• Manufacture products that are safe, effective, value for money and produced in full compliance with all appropriate legislation and standards

• Invest in maintaining manufacturing facilities that arefirst class

• Operate to high environmental and ethical standards

• Invest in training employees

• Listen to customers

The result is a progressive and innovative company whose namecan be trusted – Robinson Healthcare.

About Robinson Healthcare

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Introduction

The use of high quality, single use medical examination gloves has played an essential part incontrolling HealthCare Associated Infections (HCAI), along with correct hand hygiene policies –safeguarding both healthcare workers and patients. As a result the market has grown rapidly witha bewildering proliferation of glove types of widely varying performance and cost. Choosing theright glove, with the correct performance specification has become difficult. Consequently, manytrusts now order a multitude of gloves, pushing costs up at a time when budgets are challenging.

Quality, Performance and ProtectionReadigloves® is the new name in high quality, highperformance single use medical examination gloves - fromRobinson Healthcare. Designed to complement the extensiverange of healthcare consumables already manufactured andsupplied by Robinson Healthcare, such as Instrapac® singleuse instruments, the Readigloves® range has been carefullyselected to provide a solution to the overwhelming majority ofexamination and general purpose uses for disposable glovesby medical professionals.

The result is a focused range from which it is quick and easy toselect the most appropriate glove, avoiding costly proliferationof stock for purchasing managers, whilst providing the rightchoice of glove to match the task for the user.

As a minimum specification, all products in the Readigloves®range are fully compliant with the Medical Devices Directive93/42/EEC and the PPE Directive 89/686/EEC for MinimalRisks. For more onerous or specific tasks, specialist gloves areoffered to complete the range. A full explanation of regulatorycompliance, product standards and testing is provided on thefollowing pages.

New Generation TechnologyThe Readigloves® range features some of the latest, advancedformula materials and manufacturing technology to deliverhigh quality, high performance protection without breakingbudget constraints. These techniques allow RobinsonHealthcare to offer a new generation of gloves that combinedexterity, tactility and comfort with strength, durability andchemical resistance at economical prices.

The range offers gloves for all medical examination andmedical general purpose tasks, with a choice of materials thatmeet a variety of needs. As well as being suitable for medicalpurposes, Readigloves® can be used for a multitude ofeveryday tasks – where the superior performance designed formedical use is more than enough for more routine tasks. Somegloves in the range are also certified for use in laboratories.

Readigloves® are constructed from the following materials:

Nitrile

Latex

Vinyl (synthetic stretch vinyl and standard vinyl)

Nytraguard® is the Readigloves® brand name for nitrileexamination gloves. Nitrile is quickly becoming the materialof choice for many healthcare workers as it has a similarperformance to latex for many tasks, but is more durable andbenefits from being free of any latex proteins, which can causeType l allergy problems for some individuals. Nytraguard®gloves are made from a synthetic polymer – acrylonitrilebutadiene – that is typically stronger and more durable thantraditional latex gloves.

Nytraguard® gloves have the following features & benefits:

Fingertip texturing for good grip but lower grip palms for patient comfort

High stretch and elastic properties, for superior wearer comfort

Superior sensitivity and dexterity from thin, advanced technology gloves

Excellent strength, toughness and durability, even though the gloves are thin

High puncture resistance

Excellent resistance to tearing and ripping, particularly when donning

Highest resistance to chemicals, particularly cleaning chemicals and petroleum based solvents and oils

Excellent barrier protection against biological organisms and viral penetration

Latex free construction, to prevent Type l (latex) allergies and sensitisation

Versions independently certified for laboratory use

Unique sulphur free, accelerator free version for ultra low dermatitis potential

It is generally assumed that because nitrile does not containlatex that it will never cause allergic reactions – but this is nottrue. During the manufacture of nitrile, chemical acceleratorsare used to speed up the curing process. These acceleratorsmay cause a Type lV (chemical) allergic reaction in someindividuals which can lead to dermatitis. This is true of allstandard nitrile gloves from different manufacturers. Constantwashing of hands by healthcare workers often damages theskin, which makes the hands more susceptible to reactionsfrom chemicals. A solution offered in the Readigloves®Nytraguard® range is a ground breaking glove using the verylatest generation material, which is not only accelerator freebut also sulphur free. Its name? Nytraguard® ChemoPure®

Providing Protection for People

Nytraguard®

Nitrile Gloves

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Cyraguard® is the Readigloves® brand name for latexexamination gloves. Latex is the traditional material used toproduce examination gloves, manufactured from naturalrubber latex (NRL) extracted from rubber trees. Latex glovesoffer high performance thanks to the highly elastic propertiesof NRL.

Cyraguard® gloves have the following features & benefits:

Superior grip for precision tasks

Excellent stretch and conformability, offering the very highest user comfort

Superior sensitivity and dexterity as the gloves can be made thin and are close fitting

High strength and durability with excellent tear resistance –even when punctured

Easy and consistent donning, as the material is highly elastic and moulds very easily to the hand

Excellent barrier protection against biological organisms, viral penetration and some chemicals

One drawback to natural rubber latex is that some individualscan develop an allergy or sensitisation to the latex proteinswithin the material – called a Type l (Latex) allergic reaction.Cyraguard® latex gloves undergo special treatments duringprocessing to greatly reduce these proteins, but they cannotbe eradicated all together. Because of this risk and to simplifyprocurement, many trusts now have a ‘no latex’ glove policy.However, latex gloves still remain high performance productsthat offer the best comfort, tactility and grip.

Vinoguard® is the Readigloves® brand name for vinyl gloves.Vinyl is a synthetic polymer, more commonly known aspolyvinyl chloride (PVC). To make the rigid polymer flexibleand suitable for use as a glove, plasticisers are added, suchas phthalates. Vinyl gloves are latex free but can still causedermatitis in wearers, due to the chemicals they contain. Vinylgloves are of lower performance than both nitrile and latex butdo offer a low cost option for low risk tasks.

Vinoguard® gloves offer the following features & benefits:

Smooth finish, highly suitable for washing patients or handling fragile skin

Low elasticity, but strong enough to prevent ripping on donning

Generally lower comfort but satisfactory if the glove isbig enough

Stretch synthetic vinyl versions available for improved fit and comfort

Latex free construction, to prevent Type l (latex) allergies and sensitisation

Basic barrier protection against biological organisms and viral penetration

Minimal resistance to chemicals, suitable for non hazardous tasks only

Low cost, suitable for frequent, low risk generalpurpose tasks

It should be noted that many vinyl gloves available on themarket today do not comply with the Medical DevicesDirective. All products in the Readigloves® Vinoguard® rangecomply fully with the Directive and may be used for medicalexamination purposes. The Vinoguard® range also includesa stretch vinyl product, often referred to as synthetic orpigmentised vinyl, which is formulated to deliver improvedstrength and elasticity, improving comfort, fit and sensitivityin use.

Cyraguard®

Latex Gloves

Vinoguard®

Vinyl Gloves

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Legislation & Standards

Compliance with appropriate legislation and standards is fundamental to Robinson Healthcare’sphilosophy in all areas of the business, including the Readigloves® range. The result is high qualityproducts that not only exceed the necessary product and manufacturing standards, but also meetthe rigorous demands of our customers. Readigloves® are covered by two main regulations and anumber of product standards, which are detailed below.

Medical Devices Directive 93/42/EEC,as amended by 2007/47/ECThis legislation covers all products in the Readigloves® rangeand is the principal legislation with the exception ofNytraguard® ChemoPure®, which is primarily covered by thePPE Directive. Medical devices are classified according to theinherent degree of risk to the patient or user, associated withtheir use and how invasive the device is during use.

Readigloves® are categorised as Class l Medical Devices asthey are non-invasive and are considered a comparatively lowrisk. However, the directive places legal obligations on themanufacturer to ensure that the devices are safe and fit fortheir intended purpose, such as gloves providing a suitablebiological barrier and retaining their integrity during use.

Every device must meet a number of “Essential Requirements”as stated in Annex l of the Directive. Demonstration that thedevice complies with these requirements forms part of thetechnical documentation required for all classes of device.

These requirements include:

Safety of patients and users

Eliminating or addressing any risks associated with useof the product

Performance of the device, initially and over life

Biocompatibility, toxicity and flammability

Elimination or reduction of any infection risk

Appropriate environmentally controlled manufacturing conditions

Correct unambiguous labelling

Conformance with appropriate product standards

The manufacturer should also operate an appropriatequality management system - for medical devices this isISO 13485:2003 - and be registered with the CompetentAuthority responsible for regulatory compliance. In the UK thisis the Medicines and Healthcare products Regulatory Agency(MHRA). After issuing a declaration of conformity and applyinga CE mark, the product may be placed on the market. Themanufacturer must then maintain Post Market Surveillanceand take corrective action where required. More detailedinformation about the Medical Devices Directive and regulatorycompliance can be found at www.robinsonhealthcare.com.

Personal Protective Equipment (PPE) Directive89/686/EECThe term ‘PPE’ covers any item designed to be worn or heldby an individual for protection against one or more health andsafety hazards. This is the principal legislation for gloves thatare used in a laboratory or in a clinical setting for morehazardous tasks such as for the administration ofchemotherapy drugs. It is therefore the most pertinentregulation for Nytraguard® ChemoPure®.

However, all gloves fall under the legislation as they may beused to handle cleaning chemicals.

The Directive provides a list of ‘simple’ and ‘complex’ designPPE and the manufacturer must decide to which category anitem belongs. This is defined as follows:

Simple Design – Protects against minimal risks. The user can assess the level of protection required. The effects of the risk are gradual and can be safely identified by the user in good time.

Complex Design – Protects against mortal danger, or against danger that may seriously and irreversibly harm health. The user cannot identify the immediate effects in sufficient time.

Intermediate Design – Protection against risks that are not included in the exhaustive lists of simple or complexdesign PPE.

The manufacturer must compile a technical file that detailsthe following:

Full design specification of the PPE

List of basic health and safety requirements relating tothe PPE

Details of the European standards to which the productis manufactured

Details of other national standards to which the productis manufactured

Performance characteristics of the PPE

If the PPE is of simple design, the manufacturer can make aself declaration of conformity to the Directive and place theproduct on the market, applying the CE mark. For complexdesign PPE, the manufacturer must submit the item for ECType Examination by an approved, independent Notified Body.The manufacturing must also be subject to one of two qualitycontrol systems, also audited by the Notified Body. Anappropriate quality management system, such as ISO 9001should be employed. If approved, the Notified Body will issue acertificate of conformance and the manufacturer may apply theCE mark with the Body’s identification number and then marketthe product.

Nytraguard® ChemoPure® has been independently certified toArticle 11B of the PPE Directive 89/686/EEC, as a Category lllcomplex design device and has been tested for high resistanceto chemotherapy drugs and viral penetration. It therefore maybe used for the administration of chemotherapy drugs and forappropriate laboratory use. All other products in theReadigloves® range conform to the Directive as Category lsimple design devices for minimal risks.

It is a legal requirement for all tasks that a risk assessmentshould be undertaken before selecting which glove should beused. This should form part of your organisation’s health andsafety policies. Gloves classified for minimal risks should NOTbe used for laboratory tasks.

Medical Device Classification

Class I Low risk (eg. Bandages; Gloves)Class IIa Medium risk (eg. Single use instruments)Class IIb Medium risk, complex design (eg. Wound contact layers)Class III High risk (eg. Pacemakers)

PPE Classification

Category Risk Example of Protection Simple Design Minimal Cleaning materials of weak actionPPE (Category l)

Intermediate Design Intermediate Not covered by simple or complex listPPE (Category ll)

Complex Design Serious Chemical attack (limited protection)PPE (Category lll)

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Legislation & Standards

EN 455: Medical Gloves for Single UseThis standard is divided into four parts to cover specificrequirements:

EN 455-1: Requirements and Testing for Freedomfrom Holes

This standard covers the requirements and testing of glovesfor freedom from holes, with regard to penetration resistance.The standard uses a water leak test that is carried out usingAQL (Acceptable Quality Level) statistical sampling techniquesbased on production batch sizes. Gloves are tested by fillingwith water and observing for leaks. To comply, an AQL of 1.5or better is required (only 1.5% or less of the batch size mayhave a hole present).

EN 455-2: Requirements and Testing for Physical Properties

This standard covers physical properties such as dimensionsand force at break (minimum tensile strength) to ensure that thegloves meet minimum strength requirements to maintain theirintegrity in use. Minimum requirements are shown below.

* width across palm

EN 455-3: Requirements and Testing for BiologicalEvaluation

This standard includes test procedures for measuring powderresidue for powder free gloves and leachable proteins in naturalrubber latex gloves, to determine levels of potential allergensand to disclose information to users. Gloves that contain ≤ 2mg/dm2 of powder may be considered powder free. It is notpermissible to label latex gloves as low protein. Readigloves®Cyraguard® latex gloves contain a maximum 50 mg/dm2 oflatex protein.

EN 455-4: Requirements and Testing for Shelf LifeDetermination

This standard covers the protocol to be followed to evaluate thegloves shelf life by using real time studies or a suitably validatedalternative for accelerated ageing. This also provides the userwith storage conditions to help maintain the integrity of theglove for the stated shelf life.

EN 374: Protective Gloves Against Chemicalsand Micro-organismsThis standard covers the requirements for gloves to protect theuser against chemicals and/or micro organisms. This standardis divided into 3 parts:

EN 374-1: Terminology and Performance Requirements

This section covers the performance requirements, markingof gloves and information to be supplied by the manufacturer.It does not specify requirements for protection against anymechanical hazards.

EN 374-2: Determination of Resistance to Penetration

This section describes the method of testing to determineresistance to penetration by micro organisms by way of a waterleak test and, if practicable, an air leak test. To comply with thestandard, the glove must achieve an AQL of 1.5 (see alsoEN455-1).

EN 374-3: Determination of Resistance to Permeationby Chemicals

This section describes the method of testing to determineresistance to penetration by solid or liquid chemicals. Thecurrent standard is limited in that the test only refers to 12chemicals. To comply with the standard, the glove must havea breakthrough time of at least 30 minutes for a minimum of3 of the 12 chemicals, which should be indicated on thepackaging. If the glove is required to have resistance tochemicals other than the 12 listed in EN 374-3, the user shouldrefer to the manufacturer for evidence of testing against therequired chemicals.

Dimensions of examination gloves

Size Median length (mm) Median width* (mm)

Extra Small > 240 < 80

Small > 240 80 + 10

Medium > 240 95 + 10

Large > 240 110 + 10

Extra Large > 240 > 110

Force at break of examination gloves

Type Before ageing (Newons) After ageing (Newtons)Nitrile > 6 > 6Natural Rubber Latex > 6 > 6PVC (Vinyl) > 3.6 > 3.6

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Legislation & Standards

ASTM D6978-05: Resistance of Medical Glovesto Permeation by Chemotherapy DrugsThis standard, issued by ASTM International (American Societyfor Testing and Materials) specifically covers resistance topermeation by chemotherapy drugs and is more rigorous thanthe European standard EN 374-3 as it classifies breakthroughat a much lower permeation level. The standard measures theresistance by actual breakthrough detection time of amandatory list of seven drugs, plus two more of themanufacturer’s choice.

ASTM F1671: Resistance of Protective Clothingto Penetration by Blood-Borne PathogensThis standard is more rigorous than EN 455-1 and EN 374-2as it measures resistance to penetration to blood bornepathogens, specifically Hepatitis B and C and the HIV virus,using a surrogate microbe. This more closely reproduces theaction of micro organisms than using water or air leak tests andis therefore a higher standard for laboratory use whereresistance to micro organisms is required.

ASTM F1342: Test Method for ProtectiveClothing Material Resistance to PunctureThis standard specifically measures a material’s resistance topuncturing, using a probe of specific dimensions. This is usedto simulate as closely as possible the action of pointed objectscoming into contact with the glove.

EN 420: Protective Gloves: GeneralRequirements and Test MethodsThis standard covers the requirements for protective glovesand includes: glove design; sizing; construction;innocuousness; comfort and efficiency; marking andinformation to be supplied. If the glove has been independentlycertified as complex or intermediate design, the Notified Bodyidentification number should appear. Otherwise, the markingsshould clearly state that it is for ‘Minimal Risks’ only.

AQL (Acceptable Quality Level)AQL is a method for determining the performance of a productagainst set quality assessment criteria using statisticalsampling techniques based on production batch sizes.It measures the maximum number of defective goodsconsidered acceptable in a sample size. An AQL of 1.5, whichis generally applicable to medical examination gloves, infersthat statistically up to 1.5% of the batch may be defective,which is an excellent standard for mass production, low costgloves with their inherent characteristics.

Legislation & Standards (Cont)

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Choosing the Right Glove

The Facts!

Choosing the correct gloves to provide protection during various tasks is not alwaysstraightforward. Some tasks require greater dexterity and tactility, as small objects need to behandled. Others require superior grip characteristics to securely hold items such as instruments.Whatever the task, gloves should fit well, be comfortable and not cause hand fatigue. Nitrile, latex and vinyl gloves all have their own characteristics which means that their performance rating varies depending on thetask to be performed and the individual needs of the person using the gloves. Therefore, we have created a performance guide foreach glove in the Readigloves® range, to help you select the most appropriate product based upon the characteristics of the gloverather than the specific task.

The table on page 11 provides guidance on the performance of each glove against each characteristic. An explanation of eachcharacteristic is provided below.

Biological Barrier

This is probably the most critical consideration for any glove. Medical examination gloves wereoriginally invented to create a physical barrier, reducing the chance of cross infection betweenhealthcare worker and patient. This is still paramount. Once this barrier is breached, the consequencescan be serious, particularly if exposure to blood or other body fluids is likely.

The molecular composition of the glove is critically important. Many materials contain microscopicpores, which can let micro-organisms pass through, creating a biohazard and cross contamination risk.Generally latex and nitrile gloves offer exceptionally high micro-organism barrier characteristics.Some – such as Nytraguard® Chemopure® - have been extensively tested and achieve an extremelyhigh barrier performance. Vinyl gloves offer a much lower barrier performance even though they maycomply with the appropriate standards.

Manufacturing gloves is a complex process and failure in any part of that process can lead to a poorquality glove. The material formulation has to be consistent and each production stage carefullycontrolled. If this is done, a glove of the correct weight, thickness, elongation, strength, durability andpuncture resistance will be produced and it is this combination of features that ensure that the glovesprovide an effective biological barrier.

Durability and Strength

It is essential that gloves retain their integrity during use. Gloves are subject to abrasion and wearduring use, such as handling instruments, unscrewing bottle caps etc. This can cause the glovematerial to tear or puncture, leading to a cross infection risk or ingress of chemicals if in a laboratorysetting.

Nitrile and latex are much more durable than vinyl gloves due to their molecular composition.When comparing gloves made from the same material, it is usual that heavier weight gloves are moredurable. The underlying concept of the Readigloves® range is that different thicknesses of gloves areoffered in every material type. This enables the user to choose a glove exactly tailored to the task athand. If you need more durability - go thicker. If you need more tactility and comfort – go thinner.This is only a rule of thumb, so we have provided a comparison chart on page 11 to help you.Note that an important exception to this is Nytraguard® Bluple®, which is made from an advancedformula of nitrile that makes it very durable, comfortable and tactile – a unique combination of features.

Puncture Resistance

It is vital that a glove does not puncture if it is snagged or caught when handling any object.Once punctured, the glove fails to provide protection to the user or patient. For example, manipulatingsharp instruments or moving apparatus may snag the glove on a sharp edge or trap the material.Even fingernails can cause punctures, so it is recommended that nails are kept short andjewellery removed.

This risk can be minimised by selecting a glove material that is more resistant to puncturing. Nitrile issignificantly the most resistant material to puncturing from contact with pointed implements, but itshould be noted that when punctured a tear develops quickly. Latex offers less resistance topuncturing, but once punctured does not tear as quickly as nitrile. Vinyl is the least resistant topuncturing. The molecular composition of stretch vinyl however, such as Vinoguard® Synthetic,does provide added resistance compared to standard vinyl. When comparing gloves made fromthe same material, heavier weight gloves perform better in this regard.

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Tear Resistance

How often have you tried to use a glove, only to find that it rips and tears as you pull it on? Some glovescan tear during donning or during use. This can be costly, as a damaged glove has to be discarded,not to mention the loss of protection. Reducing the possibility of tearing can be achieved by selecting thecorrect type of glove and also buying a better quality glove – gloves are most definitely not made equal.It is more cost effective to purchase a material that is less prone to rip and is manufactured to a higherquality, than to waste gloves by throwing them away.

Again, the more ‘stretchy’ a glove is, the less likely it is to rip. Latex gloves offer excellent tear resistancedue to their molecular structure. Nitrile also offers good tear resistance. Vinyl is the most likely to tear(usually during donning), though stretch vinyl will provide improved tear resistance, as it is more elasticand a heavier weight than standard vinyl.

Grip and Texturing

The requirement for grip varies with the task being performed. For example, when manipulating aninstrument during a surgical procedure, it is critical that the glove provides a firm and reliable grip ofthe instrument. This is even more important if the gloves are wet. However, for tasks such as washinga patient, or holding an elderly person it is more important that there is a lower level of grip, so as notto cause pain or damage fragile skin.

The level of grip is determined by two factors – the molecular construction of the material and whetherthe surface has a texture applied. Latex offers the maximum grip. It is naturally ‘grippy’ and also tendsto have an all over micro-textured finish to increase this further. Nitrile has moderate natural gripcharacteristics and generally has a textured finger tip finish to offer high grip for procedures such asholding or manipulating instruments, but moderate grip on the palm for patient comfort. Vinyl offers theleast grip. It naturally has a smooth, slippery finish and does not normally have any texturing applied.This makes vinyl ideal for personal hygiene tasks but poor for more critical tasks. Vinyl is ideal for careof the elderly and is comfortable for the patient when washing the body, particularly the hair.

Fit, Conformability and Comfort

Everybody has different shape hands and fingers. This can present problems when trying to find a gloveto fit well, so that the task can be more easily performed and the glove is comfortable to wear. For taskswhere this is important, the glove should stretch to produce a good fit and mould, or conform, to theshape of the hand. It should also be tight enough, but not so tight that it takes more effort to bend thefingers, which causes fatigue. Thicker, heavier weight gloves tend to cause more finger fatigue as theytake more force to stretch the material.

Materials with high stretch or elongation properties, such as latex and nitrile, conform well to the hand.Stretch also improves resistance to ripping or tearing, particularly during donning. This conformabilityalso improves dexterity, which is essential for complex tasks. Vinyl – and even stretch vinyl - have lowerlevels of stretch than nitrile or latex. Therefore, sometimes a larger glove has to be selected to ensure acomfortable fit and minimise ripping when donning. This can lead to a baggy fit. Stretch is generally lesscritical however, when performing personal hygiene or janitorial tasks.

Tactility and Sensitivity

When performing complex tasks it is usually essential that sensitivity of touch is maintained. This isespecially true if handling small objects, or holding delicate items. Thin walled, close fitting gloves offerthe best sensitivity and tactility, but they must also have a high stretch performance so that the handcan move easily enough, without feeling tight and causing fatigue.

Latex offers superior performance for sensitivity, followed closely by the latest technology thin wallednitrile gloves like Nytraguard® Bluple®. Increasing the thickness and weight of both latex and nitrile glovesdecreases the sensitivity, but they are still significantly better than the best vinyl gloves. Vinyl does notstretch well and thin wall construction versions are not very strong, leading to easy ripping and tearing,particularly during donning.

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Resistance to Chemicals

When tasks involve the handling of, or contact with chemicals, the glove should be chosen with greatcare. A risk assessment of the task should be undertaken before selecting which glove should be used.This is a legal requirement for all tasks, whether they involve contact with chemicals or not and shouldform part of your organisation’s health and safety policies.

The primary legislation is the PPE Directive 89/686/EEC, rather than the Medical Devices Directive.Many tasks are assessed as minimal risk and commonly referred to as ‘simple design PPE’. This includesgloves that are used for cleaning tasks using diluted, mild detergents.

If the task is more onerous then ‘complex design PPE’ must be used and the law requires that acertificate of conformity is issued by an independent Notified Body. This includes gloves used for thehandling of specific chemicals used in laboratories, or the administration of cytotoxic drugs duringchemotherapy. The user should always obtain a copy of the manufacturer’s certificate of conformanceto ensure the chemicals being handled are covered by the scope of the certificate.

Nitrile gloves generally offer excellent resistance to chemicals. Latex also provides good performance,but is poor with petroleum based chemicals and oils. Generally vinyl gloves offer the least chemicalresistance but are suitable for use with diluted detergent solutions.

Allergenic Potential

Anyone who wears gloves can suffer from a glove-associated irritation. Some individuals can also havean allergic reaction to specific allergens within the gloves. Repeated exposure by wearing gloves regularlycan increase the person’s sensitisation to the point where a reaction occurs and symptoms are displayed.

Latex Allergy - The most publicised, because of its potentially serious nature, is a Type l Natural Rubber Latex (NRL) Protein Allergy – often referred to as latex allergy. Latex contains a naturally occurring protein, which to some individuals is an allergic compound. Symptoms can vary from itchy or runny eyes and facial swelling up to more serious conditions such as anaphylactic shock or cardio-respiratory arrest. Users must stop using latex gloves if they experience any symptoms. If patients have an allergy, healthcare workers must use an alternative glove type. Latex gloves from the Cyraguard® range are specially treated so that most of the proteins are removed, but individuals who develop a sensitisation to the material should still avoid latex.

Contact Dermatitis - The most common, but least publicised allergy is a Type lV Chemical Allergy, which is often referred to as contact dermatitis due the symptoms that are displayed. It is believed thatthis type of allergy is caused by contact with the residues of chemical accelerators and sulphur used in the vulcanisation process of acrylonitrile butadiene gloves. Symptoms of contact dermatitis include itchy and reddened skin, blistering, cracking and open lesions, which can be very painful for sufferers.

Irritation - Sweating inside the glove, not allowing the skin to breathe or friction from tight gloves can cause irritation. Dermatitis is also commonly experienced in sensitive individuals using vinyl gloves.

To help avoid allergies, the Readigloves® range includes Nytraguard® ChemoPure®. This is a nitrile glovethat has been manufactured free of accelerators and sulphur to produce a glove that is both latex free andpresents an ultra low dermatitis risk. This glove is the ideal choice for users or individuals that have Type land Type lV allergic reactions.

Please refer to the performance table on the opposite page to help select the correct glove for you andthe task.

Ease of Donning

Some gloves are simply harder to don, or put on, than others. This is affected by a number of factors.These include the size and shape of your hand, the size of the glove, how easily the glove stretches, thethickness (or weight) of the glove and its strength. If the optimum size, stretch and thickness is notselected, the glove can be very difficult to don and will easily tear during the attempt. Having wet or damphands also makes gloves more difficult to don.

Generally, latex gloves are the easiest to put on as the material is strong, stretches and conforms to thehand and is resistant to tearing. Nitrile gloves also perform very well, particularly the new advancedmaterials such as Bluple®. Both Cyraguard® latex and Nytraguard® nitrile glove ranges have an advancedinternal treatment to make the glove easier to slip on. Vinyl generally is the most difficult to don due to themore rigid nature to the material. To overcome this, a larger size may be selected, but the glove willprobably be baggier when worn.

IMPORTANT NOTE – Robinson Healthcare offer a sample service for the entire Readigloves® range.This is the best way to check which size you need before purchasing bulk stock, as one manufacturer’ssize is sometimes different to the ‘same size’ from another supplier. See page 27 for more details.

AllergySafe

Choosing the Right Glove - The Facts! (Cont)

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Powder Content

The addition of powder used to be a popular method to aid the donning of gloves and is still used bysome manufacturers today. However, powder presents a cross infection risk through direct contact oraerosolisation (dispersal in air) when removing the glove. It can also be an irritant and can trigger anallergic reaction. For this reason, all products in the Readigloves® range are supplied powder free.Instead, our Cyraguard® latex and Nytraguard® nitrile glove ranges have a special internal treatment thatmakes the interior surface of the glove more slippery and therefore easier to don.

Glove Selection & Performance Indication Guide

This table shows a relative evaluation of glove performance.

Characteristic Bluple® SkyBlue Tough ChemoPure® Premium Essentials Synthetic Premium Essentials

Biological Barrier 9 9 10 10 10 9 5 4 3

Durability & Strength 8 9 10 9 9 7 5 4 3

Puncture Resistance 8 9 10 9 7 6 4 3 2

Tear Resistance 9 9 10 9 10 7 4 3 2

Frip & Texturing 8 8 8 8 10 10 2 2 2

Fit, Conformability & Comfort 9 8 7 8 9 10 4 3 2

Tactility & Sensitivity 9 8 7 8 9 10 4 2 3

Resistance to Chemicals* 8 9 10 10 7 7 2 2 2

Latex Allergy Latex Free 5 5 Latex Free

Contact Dermatitis 7 7 7 10 7 7 6 6 6

Ease of Donning 9 9 8 9 9 9 5 3 2

Powder Content Powder Free Powder Free Powder Free

Scale: 1 = Worse/Very Poor Performance, 10 = Best/Excellent Performance. Note* - Actual performance is dependant on the chemical

Nitrile Latex Vinyl

Nytraguard® Cyraguard® Vinoguard®

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Ad

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Use Advice on Use

Suggested ‘dos and don’ts’ when using glovesBefore using a medical examination glove you should think carefully about which glove to use, the task you need to perform and how theglove should be used, including any precautions to maintain the integrity of the glove. Here is our suggested list of ‘dos’ and ‘don’ts’:

Notes

1. These suggestions are purely for guidance only. The exact choice of glove is subject to your organisation’s health and safety policy, or alternatively by conducting a risk assessmentand selecting the glove based upon specification and performance.2. Where a specific Readigloves® range product is not specified and a ‘range’ is suggested, the most appropriate glove should be more closely identified by performancecharacteristics, shown on the individual product pages and summarised on page 11.

Do….

…follow your organisation’s health and safety policy(or conduct a risk assessment)

…ensure hands are properly washed and thoroughlydried before donning gloves

…if you have a Type l (latex) or Type lV (chemical) allergy, select an appropriate glove

…choose the correct size glove to minimise tearingand maximise dexterity

…select the correct glove according to performance characteristics for the intended task

…keep fingernails short and remove jewellery before donning to prevent puncturing

…adhere to your organisation’s infection control guidelines during use

…replace gloves if they are torn or punctured

…dispose of gloves immediately after use in accordance with your organisation’s waste policies

…always wash your hands after removing gloves

Don’t….

…store gloves under high ambient temperatures,near direct heat, in direct sunlight or exposed to fluorescent lighting

…use the same gloves for multiple tasks if cross infection is possible

…wear gloves in between tasks/procedures

…continue to use if exposed to biological hazardsfor prolonged periods of time

…handle equipment or stationery whilst wearing gloves, to avoid contamination

…macerate after use

…dispose of gloves carelessly

…replace good hand washing/hygiene with gloves

Choosing a glove by applicationThe previous section of this catalogue details the most appropriate way to select the correct product based upon the characteristicsof the glove rather than the specific task. However, for a quick and simple guide to the most likely glove type required for various tasks,please use the suggestions below.

Application First Choice Alternative Choice

Hospital – clinical procedures Cyraguard® range Nytraguard® range

Hospital - routine patient care Nytraguard® range Vinoguard® Synthetic

Hospital – administration of Nytraguard® ChemoPure® N/Achemotherapy drugs

Emergency services Nytraguard® range Cyraguard® range

Dental clinics Cyraguard® range Nytraguard® range

GP surgeries Nytraguard® Bluple® Vinoguard® Synthetic

Community nurses Nytraguard® range Cyraguard® range

Laboratories Nytraguard® ChemoPure® N/A

Care homes Vinoguard® Synthetic Vinoguard® range

Nursing homes Nytraguard® Bluple® Vinoguard® range

Community care Nytraguard® Bluple® Vinoguard® Synthetic

Councils/Social services Nytraguard® Bluple® Vinoguard® range

General cleaning/janitorial Nytraguard® range Vinoguard® range

Food & catering Nytraguard® Bluple® Vinoguard® range(non fatty foods only)

HM Customs/Airlines Nytraguard® range Cyraguard® range

Motor vehicle garages Nytraguard® range Vinoguard® range

Hair & beauty salons Vinoguard® range Nytraguard® Bluple

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Nytraguard®

Nitrile Gloves

Bluple®

SkyBlue Tough ChemoPure®

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14

Nytraguard

® Bluple

®

Nitrile Gloves

Nytraguard® Bluple® is no ordinary glove. It is the very latest innovation for high performancenitrile gloves, combining light weight, high comfort and great sensitivity with toughness – anunbeatable combination. Bluple® is perfect for the majority of tasks in a healthcare setting butcan also be used for a huge variety of general tasks requiring hand protection.

Bluple® Less is more

The heart of a Bluple® glove is its state of the artacrylonitrile butadiene polymer formula, allowing a highstrength, high stretch, thin wall construction that was notpossible until now. This delivers incredible benefits.

Bluple® Thin wall technology

Sensitivity and dexterity are the most critical attributesrequired for a medical glove – and this is where Bluple®really excels. Even the smallest objects can be felt throughthe thin walls for optimum sensitivity. Bluple® also deliversdexterity because the combination of thin walls with highstretch means that it is very easy to move the hand withminimal effort. The glove also conforms beautifully to thehand and has the benefit of being extremely comfortableto wear with minimum hand fatigue. Bluple® is also flexible,making it very easy to put on and remove, whilst the thinwalls reduce hand heat and so reduces sweating.

These features are just not possible withconventional nitrile gloves.

Bluple® Dependable, durable and versatile

Critically, any glove must offer protection. In a clinicalsetting this is not just for the clinician but also to preventcross infection to the patient. The advanced material ofBluple® gloves, coupled with state of the art manufacturingplants and regular production quality checks in factorybased laboratories, ensures that Bluple® is producedwithout microscopic holes that would otherwise lead toviral penetration and tearing.

Durability is also extremely important. Not only are Bluple®gloves strong, they are specially treated inside so that theyslip onto the hand with the minimum of drag, reducing thechance of ripping. Bluple® gloves are also manufactured asstandard with a textured fingertip finish to providedependable grip during precision tasks and aiding wet grip.Palms and the lower finger area have a matt finish –to provide grip without causing discomfort when holdinga patient’s skin.

Bluple® gloves are powder free, eliminating skin irritationand infection risk from organisms being carried in powder.Additionally, as the gloves are manufactured fromacrylonitrile butadiene they do not contain latex, makingthem safe to use by individuals who are sensitive to latex.

Nytraguard Bluple®®

Technical Performance

Classification: Single use, Non sterile Class I Medical Device

Materials: Acrylonitrile butadiene; Does not contain latexDoes not contain styrene; Powder free

Design: Ambidextrous, finger textured outer surface, beaded cuff

Inspection Criteria: AQL 1.5

Shelf Life: 3 years

Regulatory Principal legislation: Medical Devices Directive 93/42/EECCompliance: Other legislation: PPE Directive 89/686/EEC Minimal Risks

Product: EN 455-1; EN 455-2; EN 374-2 Level 2Production: ISO 13485; ISO 9001

Applications: Medical examination; medical general purpose; routine patient care; care of the elderly; professional care in the home; general tasks; food preparation

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Nytraguard

® Bluple

®

Product Code Size Gloves per Carton Unit of Sale

9535 Extra Small 100 10 Cartons9536 Small 100 10 Cartons9537 Medium 100 10 Cartons9538 Large 100 10 Cartons9539 Extra Large 100 10 Cartons

9545 Extra Small 200 10 Cartons9546 Small 200 10 Cartons9547 Medium 200 10 Cartons9548 Large 200 10 Cartons9549 Extra Large 200 10 Cartons

Bluple® Meets all health and safety and legal requirements

Bluple® is a Class l Medical Device for Medical Examinations.This means that it is suitable for a huge variety of clinical tasksin hospitals, community clinics, GP surgeries, dentistry clinics,ambulances, nursing and care homes. Bluple® also conforms tothe PPE Directive for minimal risk tasks, making it an excellentchoice for general purpose tasks. It is great for cleaning where itis important that a single use glove is used for infection controlreasons – perfect in a clinical setting. Its durability means thatthe gloves will last without the need for frequent changing.

Bluple® is also suitable for food preparation, where it is criticalthat the food is not contaminated – particularly in a hospitalsetting. It offers a much higher level of performance thanvinyl gloves – giving better dexterity and better durability.

Bluple® Economical and better for the environment

Bluple® is economical with the materials it uses and the costin use. The new material means that the gloves can be madethinner, but actually perform better than thicker gloves. Moregloves can also be fitted into a box, reducing packaging and theroom taken up in transport – thus reducing the carbon footprint.

The savings made in using less material and lower transportcosts make Bluple® economically priced – as these savings arepassed on to you, the user! Bluple® is also available in cartonsof 200 gloves in addition to the standard 100. This offersadditional savings is use, by reducing labour required to replaceempty boxes in high use applications.

Once again – the use of new technology proves that “less reallyis more”. Bluple® truly means less material, more benefits forthe environment and more savings for you.

EN 374-3EN 374-2

Level 2

AQL1.5

Bluple® Main features and benefits

Safe

Sensitive

Strong

Comfortable

Dexterous

Dependable

Durable

Economical

Environmentallyconscious

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Nitrile Gloves

Nytraguard® SkyBlue is a high quality nitrile glove that is the perfect choice where light weight,high comfort and high levels of sensitivity are paramount. It complements perfectly the othergloves in the Nytraguard® range, as it permits excellent dexterity but still offers high strength.

High sensitivity and comfort – Yet dependable

SkyBlue benefits from a thin wall lightweight constructionand so is ideal for most tasks in a healthcare environment,particularly medical examinations. The thin wall deliversexceptional levels of comfort as the glove stretches easilyand conforms to the hand. Movement and manipulation ofthe hand takes minimal effort, reducing hand fatigue so thatthe user can use gloves throughout the day without tiring.

However, don’t let the light weight construction fool youinto thinking that SkyBlue is not strong. It has a high levelof resistance and can easily withstand the abrasion receivedwhen handling apparatus or instruments. SkyBlue is strongand durable and is certainly up to the task. The texturedfingertips assist both a sensitive and sure grip of smallobjects, whilst the matt finish on the palms and lowerfingers ensure that even patients with fragile skin aresecurely held without causing any discomfort duringthe procedure.

SkyBlue – Ticking all the legal boxes

It is absolutely essential that a glove must offer protectionto both healthcare worker and patient, preventing crossinfection. SkyBlue passes the test within EN 455-1, freedomfrom holes, with flying colours – eliminating microscopicholes that would otherwise allow viral penetration. It alsopasses all other tests within the standards so that it fullymeets the requirements as a Class l Medical Device formedical examinations. SkyBlue also conforms to the PPEDirective for minimal risk tasks and as it is manufacturedfrom acrylonitrile butadiene, it does not contain latex; safefor users or individuals who are sensitive to latex.

The result is a high performance glove that is equally athome for clinical tasks in hospitals, GP surgeries, dentistsand care homes as it is for general tasks such as cleaning.

Nytraguard SkyBlue®

EN 374-3EN 374-2

Level 2

AQL1.5

Technical Performance

Classification: Single use, Non sterile Class I Medical Device

Materials: Acrylonitrile butadiene; Does not contain latexDoes not contain styrene; Powder free

Design: Ambidextrous, finger textured outer surface, beaded cuff

Inspection Criteria: AQL 1.5

Shelf Life: 3 years

Regulatory Principal legislation: Medical Devices Directive 93/42/EECCompliance: Other legislation: PPE Directive 89/686/EEC Minimal Risks

Product: EN 455-1; EN 455-2; EN 374-2 Level 2Production: ISO 13485; ISO 9001

Applications: Medical examination; medical general purpose; routine patient care; care of the elderly; professional care in the home; general tasks; food preparation

SkyBlue Main features and benefits

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Lightweight

Sensitive

Comfortable

Dexterous

Strong

Safe

Dependable

Latex Free

Product Code Size Gloves per Carton Unit of Sale

9525 Extra Small 100 10 Cartons9526 Small 100 10 Cartons9527 Medium 100 10 Cartons9528 Large 100 10 Cartons9529 Extra Large 100 10 Cartons

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Nitrile Gloves

When the going gets tough - reach for Nytraguard® Tough. Designed for extra safety and optimumdurability, Tough is a heavy gauge acrylonitrile butadiene glove and the automatic first choicewhen security and protection is the prime concern. Whatever the task, Tough is equal to it.

Tough by name – Tough by nature

Nitrile gloves are already strong and durable, thanks to thestrong bonds in the molecular structure of nitrile. Nytraguard®Tough takes this durability to the next level as it is manufacturedfrom a thicker, heavier gauge of material. Tough is a medicalexamination glove that is suitable for heavy duty tasks, such asthe handling of medical apparatus, as the risk of ripping ortearing is significantly reduced. For other tasks, includingcleaning, Tough is actually more cost effective than inferior andcheaper gloves. This is because Tough is more durable, lastslonger and avoids frequent changes to complete the task.

Despite the thicker glove wall, Tough is still very flexible and iscomfortable to wear. The glove has excellent stretchcharacteristics and conforms well to the hand, with only aminimal reduction in dexterity and sensitivity for the majority ofclinical tasks.

Tough – The glove you can trust

The most critical feature of a medical examination glove isbiological barrier protection and Nytraguard® Tough does notdisappoint in this respect. This is where Tough excels, as theheavy gauge material provides exceptional puncture resistance,preventing viral penetration and offering complete peace ofmind for the clinician and the patient. For example, Tough is lesslikely to be damaged, compared to ordinary gloves, if snaggedon an instrument. This makes Tough the perfect choice wherean increased biohazard risk exists, such as contact with bloodor body fluids.

Nytraguard® Tough also benefits from a sure grip as thefingertips are textured, keeping a firm hold on instruments,apparatus and medical equipment. As you would expect fromsuch a dependable glove, Tough passes all the requirements tobe designated a Class l Medical Device for medicalexaminations. It also conforms to the PPE Directive for minimalrisks, ensuring it is equally at home in handling detergents andretaining its integrity during more onerous cleaning and janitorialtasks. In fact – whatever the task, Tough is the glove you candepend on and trust.

Nytraguard Tough®

EN 374-3EN 374-2

Level 2

AQL1.5

Technical Performance

Classification: Single use, Non sterile Class I Medical Device

Materials: Acrylonitrile butadiene; Does not contain latexDoes not contain styrene; Powder free

Design: Ambidextrous, finger textured outer surface, beaded cuff

Inspection Criteria: AQL 1.5

Shelf Life: 3 years

Regulatory Principal legislation: Medical Devices Directive 93/42/EECCompliance: Other legislation: PPE Directive 89/686/EEC Minimal Risks

Product: EN 455-1; EN 455-2; EN 374-2 Level 2Production: ISO 13485; ISO 9001

Applications: Medical examination; medical general purpose; routine patient care; care of the elderly; professional care in the home; general tasks; food preparation

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Toug

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Tough Main features and benefits

Heavy gauge

Extra safe

Extra strong

Extra tough

Extra durable

Ultra dependable

Latex Free

Product Code Size Gloves per Carton Unit of Sale

9530 Extra Small 100 10 Cartons9531 Small 100 10 Cartons9532 Medium 100 10 Cartons9533 Large 100 10 Cartons9534 Extra Large 100 10 Cartons

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moPure®

Accelerator Free Nitrile Gloves

Nytraguard® ChemoPure® is a ground breaking glove. It is the first in a new generation of extrahigh specification, highly versatile medical gloves that provide protection in both a clinical andlaboratory environment, whilst guarding the user against the risk of contact dermatitis –a common problem for wearers of nitrile gloves. This is a unique combination and in a leagueabove ordinary gloves. But as you will read below, thanks to independent testing and certificationyou don’t just have to take our word for it.

ChemoPure® Extending the technology boundary

The key to ChemoPure® gloves is a breakthrough in newgeneration nitrile film formulation, taking glove manufacturingto the next level. Never before has a glove been able todeliver advanced protection to chemical permeation and viralpenetration, plus ultra low dermatitis potential at the sametime as high comfort, sensitivity, tactility and strength –making ChemoPure® ideal for the vast majority of clinicaltasks, plus laboratory use.

ChemoPure® Independently certified complexdesign PPE

Thanks to this advanced film formulation, the first bigdifference you will notice about ChemoPure® is that it hasbeen independently certified to Article 11B of the PPEDirective 89/686/EEC, as a Category lll complex designdevice. This is quite different to the minimal risks claimedby other gloves, which is a self declaration.

Complex design PPE, such as ChemoPure®, has to undergoa type examination by an independent Notified Body, whochecks the test results that back up the product’sperformance claims. The manufacturing facility has tobe regularly audited and approved to ensure the glovescontinue to be manufactured in conformance to the directive.

Whilst minimal risks gloves simply protect against dilutecleaning solutions, ChemoPure® is “intended to protect thewearer against mortal danger, or against dangers that mayseriously and irreversibly harm health, the immediate effectsof which the designer assumes that the user cannot identifyin sufficient time”. Which glove would you trust whenperforming high risk tasks?

ChemoPure® Advanced chemotherapy drug resistance

One of the most hazardous tasks for a clinician is theadministration of highly toxic chemotherapy drugs. As theEuropean standard, EN 374-3, does not directly addressthe resistance to cytotoxic drugs, ChemoPure® has beenindependently tested to the more rigorous ASTM (AmericanSociety for Testing and Materials) standard D6978-05.

This standard measures the breakthrough resistance to amandatory list of seven drugs, plus two more of themanufacturer’s choice. ChemoPure® performs extremelywell, even against the most aggressive drugs, Carmustineand ThioTEPA. The performance of ChemoPure® is providedin the table opposite.

It is a legal requirement for all tasks that a risk assessmentshould be undertaken before selecting which glove shouldbe used, whether they involve contact with chemicals or not.This should form part of your organisation’s health and safetypolicies. If you are using another glove for the administrationof chemotherapy drugs, how easily can you check theperformance test results? Which glove would you trust?

Nytraguard ChemoPure®®

Technical Performance

Classification: Single use, Non sterile Class I Medical Device

Materials: Acrylonitrile butadiene; Accelerator and sulphur free; Doesnot contain latex; Does not contain styrene; Powder free

Design: Ambidextrous, finger textured outer surface, beaded cuff

Inspection Criteria: AQL 1.5

Shelf Life: 3 years

Regulatory Principal legislation: PPE Directive 89/686/EEC CategoryCompliance: lll Complex Design to Article 11B

Other legislation: Medical Devices Directive 93/42/EECProduct: EN 455-1; EN 455-2; EN 374 (Excl. Pt 1 5.3.2); EN 420; ASTM D6978-05; ASTM F1671; ASTM F1342ISO 13485; ISO 9001

Applications: Laboratory use (personal protection from specific chemicals); administration of chemotherapy drugs; medical examination; medical general purpose; routine patient care; care of the elderly; professional care in the home; general tasks, food preparation

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Test Chemotherapy Drug Average BreakthroughDetection Time (mins)

Carmustine (BCNU), 16.703.3mg/ml (3,300 ppm)

Cisplatinum, No Breakthrough Up To 240 min1.0 mg/ml (1,000 ppm)

Cyclophosphamide, (Cytoxan) No Breakthrough Up To 240 min20.0 mg/ml (20,000 ppm)

Dacarbazine, (DTIC), No Breakthrough Up To 240 min10.0 mg/ml (10,000 ppm)

Doxorubicin Hydrochloride, No Breakthrough Up To 240 min2.0 mg/ml (2,000 ppm)

Etopside, (Toposar) No Breakthrough Up To 240 min20.0 mg/ml (20,000 ppm)

5 - Fluorouracil, No Breakthrough Up To 240 min50.0 mg/ml (50,000 ppm)

Paclitaxel, (Taxol), No Breakthrough Up To 240 min6.0 mg/ml (6,000 ppm)

ThioTEPA, 72.3610.0 mg/ml (10,000 ppm)

ChemoPure® Advanced viral penetration performance

ChemoPure® already passes the EN 455-1, freedom from holesstandard, which is used to determine whether a glove is aneffective biological barrier. However, to prove resistance to viralpenetration, ChemoPure® has also been tested to and passesASTM D1671. This standard is designed to more rigorously testthe glove against penetration by blood borne pathogens,specifically Hepatitis B and C and the HIV virus. This makesChemoPure® not only highly suitable, but also permissible foruse in laboratories. Remember, PPE minimal risk gloves shouldNOT be used in a laboratory – don’t take risks, chooseChemoPure®.

ChemoPure® Pure, for protection against dermatitis risk

ChemoPure® has been specially formulated to produce a glovewith an ultra low dermatitis risk for the wearer. The potential ofan allergic reaction to the latex proteins in latex gloves is welldocumented. However, the potential of a Type lV ChemicalAllergy is much higher. Standard nitrile gloves contain sulphurand chemical accelerators to assist the manufacturing process.ChemoPure® is made from a special formulation that is testedand proven to be free of these chemicals. This makesChemoPure® the perfect choice for latex allergy sufferers whoalso have a high potential for sensitisation to accelerators andsulphur. ChemoPure® is the PURE glove.

ChemoPure® Durable, comfortable, sensitive and versatile

You may think that ChemoPure® is a specialist glove that shouldonly be used for administering chemotherapy drugs, inlaboratories or if you have contact dermatitis. But you would bewrong - ChemoPure® is also a Class l Medical Device formedical examinations.

The glove is very flexible, has high strength, high stretch andconforms beautifully to the hand, with the resulting benefit ofbeing extremely comfortable to wear with minimum handfatigue. This combination also delivers great dexterity andexcellent sensitivity, vital for more complex tasks as even smalland delicate objects can be distinguished through the glove.ChemoPure® gloves are also specially treated internally so thatthey slip easily onto the hand, reducing the chance of ripping.

Advanced design delivers all of these benefits in one glove,at only a marginally higher cost than standard nitrile gloves.ChemoPure® really is a versatile glove that pushes theboundaries of glove technology.

Chemotherapy Drug Resistance Performance

ChemoPure® has been tested for permeation to ASTMD6978-05 for the chemotherapy drugs listed below. It is highlyresistant to the aggressive Carmustine and ThioTEPA drugs.Warning: Please note breakthrough time. In the event ofaccidental spillage of Carmustine and ThioTEPA werecommend glove removal within 15 minutes.

EN 374-3EN 374-2

Level 2

AQL1.5

ChemoPure® Main features and benefits

Safe

Certified PPE for laboratory use

Chemotherapy drug resistancetested

Pure – sulphur and accelerator free

Ultra low dermatitis risk

Viral penetration performancetested

High sensitivityand strength

Comfortable

Dexterous

Dependable

Durable

Latex free

ASTMD6978-05

ASTMF1671

ASTMF1342

Product Code Size Gloves per Carton Unit of Sale

9540 Extra Small 100 10 Cartons9541 Small 100 10 Cartons9542 Medium 100 10 Cartons9543 Large 100 10 Cartons9544 Extra Large 100 10 Cartons

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Cyraguard®

Latex Gloves

Premium Essentials

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Latex Gloves

High quality latex gloves have long been considered the gold standard for medical examinationuse. Cyraguard® Premium is no exception, delivering outstanding performance in the criticalareas of barrier protection, grip, comfort and sensitivity of touch and feel, matched closely forclinical use by only the latest, advanced formula nitrile gloves such as Bluple®.

Premium – When only the best will do

Cyraguard® Premium is manufactured to stringent quality levelsin a state of the art manufacturing plant that employs regularproduction quality checks, ensuring the glove performs as itpromises. Too often, cheaper latex gloves are made to lowerstandards on ageing machines, resulting in sub standardperformance with potentially serious consequences.Premium is quite different and is a glove you can trust.

Manufactured from a slightly heavier, premium gaugeof material, Premium delivers optimal biological barrierprotection, preventing viral penetration when it matters. Despitethis heavier gauge, Premium still conforms beautifully to thehand and stretches to provide an exceptionally close fit. Evensmall and delicate objects can be easily felt and distinguishedthrough the glove wall, for superior sensitivity.

Premium - Getting a firm grip on the matter

Latex is naturally a ‘grippy’ material, but to ensure optimumperformance for complex tasks and procedures, Premiumfeatures a micro textured outer surface. This deliversoutstanding performance when manipulating small, smoothinstruments and offers complete peace of mind for the clinician.This grip is superior to all other gloves. Premium is also veryresistant to tearing and rarely rips during donning.

Of course, latex gloves do contain latex proteins. This can causesensitisation and an allergic reaction in some individuals.Premium features the latest manufacturing techniques and anadvanced treatment to minimise the latex protein content to aslow a level as it possible. If a latex allergy already exists, wewould however recommend the use of nitrile gloves.

As a Class l Medical Device for medical examinations, Premiumis ideally suited to many clinical tasks in hospitals, clinics andcommunity care. It also conforms to the PPE Directive forminimal risk tasks, so is suitable for general purpose tasks.

Cyraguard Premium®

EN 374-3EN 374-2

Level 2

AQL1.5

21

Cyr

agua

rd®

Pre

miu

m

Technical Performance

Classification: Single use, Non sterile Class I Medical Device

Materials: Natural rubber latex – special treatment for low protein performance. Does not contain styrene; Powder free

Design: Ambidextrous, micro textured outer surface, beaded cuff

Latex Protein Maximum 50 micrograms/dm2.Content: Low level of leachable proteins

Inspection Criteria: AQL 1.5

Shelf Life: 3 years

Regulatory Principal legislation: Medical Devices Directive 93/42/EECCompliance: Other legislation: PPE Directive 89/686/EEC Minimal Risks

Product: EN 455-1; EN 455-2; EN 455-3; EN 455-4;EN 374-2 Level 2Production: ISO 13485; ISO 9001

Applications: Medical examination; medical general purpose; routine patient care; care of the elderly; professional care in the home; general tasks; food preparation

Safe

Premium gauge

High grip microtextured surface

High comfort

High sensitivity

High tactility

Close fit and conformability

Special advanced treatmentto improve donning andreduce leachable proteins

Product Code Size Gloves per Carton Unit of Sale

9505 Extra Small 100 10 Cartons9506 Small 100 10 Cartons9507 Medium 100 10 Cartons9508 Large 100 10 Cartons9509 Extra Large 100 10 Cartons

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Latex Gloves

Cyraguard® Essentials offers a regular gauge alternative to its slightly heavier gauge sister –Cyraguard® Premium. This reduction in material gauge does not mean a reduction in quality –indeed Essentials outperforms Premium in a number of key areas to match the choice of this glovevery closely to the task at hand.

Cyraguard Essentials®

EN 374-3EN 374-2

Level 2

AQL1.5

Technical Performance

Classification: Single use, Non sterile Class I Medical Device

Materials: Natural rubber latex – special treatment for low protein performance. Does not contain styrene; Powder free

Design: Ambidextrous, micro textured outer surface, beaded cuff

Latex Protein Maximum 50 micrograms/dm2.Content: Low level of leachable proteins

Inspection Criteria: AQL 1.5

Shelf Life: 3 years

Regulatory Principal legislation: Medical Devices Directive 93/42/EECCompliance: Other legislation: PPE Directive 89/686/EEC Minimal Risks

Product: EN 455-1; EN 455-2; EN 455-3; EN 455-4;EN 374-2 Level 2Production: ISO 13485; ISO 9001

Applications: Medical examination; medical general purpose; routine patient care; care of the elderly; professional care in the home; general tasks; food preparation

22

Cyr

agua

rd®

Ess

enti

als

Product Code Size Gloves per Carton Unit of Sale

9500 Extra Small 100 10 Cartons9501 Small 100 10 Cartons9502 Medium 100 10 Cartons9503 Large 100 10 Cartons9504 Extra Large 100 10 Cartons

Cyraguard® Essentials –Essential for optimum sensitivity

Essentials’ regular gauge material means the glove wall isthinner, which offers exceptional sensitivity of touch andfeel. This makes Essentials the perfect choice for complex,delicate procedures where high tactility is critical, such asthe use and manipulation of fine instruments. The highstretch material also provides a close fit, with the gloveconforming readily to the hand, almost like a second skin.This also makes the glove really comfortable, as minimaleffort is required to bend the fingers or manipulate thehand, reducing fatigue during use.

The high quality, state of the art manufacturing processensures that Essentials still offers excellent barrierprotection. Production is carefully controlled to result inlatex that is free of microscopic holes, preventing viralpenetration. In fact, Essentials is the perfect balance ofstrength, sensitivity, comfort and protection, for finerclinical tasks.

No fuss donning

Latex gloves are easier to don thanks to their combinationof high strength and high stretch – and Essentials is noexception. Despite having a thin wall, the glove has greatstrength due to its molecular composition.

As the glove is put on, it stretches and conforms to theshape of the hand. The elasticity means that Essentials isresistant to ripping during this procedure, minimising wasteand therefore is actually more cost effective than cheapergloves, such as vinyl.

Like Premium, Cyraguard® Essentials gloves contain latexproteins, which can cause sensitisation and an allergicreaction in some individuals. Essentials features the same,advanced manufacturing techniques and advancedtreatment, which significantly reduces the latex proteincontent and reduces potential sensitisation. If a latex allergyalready exists, we would however recommend the use ofnitrile gloves.

Essentials is a Class l Medical Device for medicalexaminations, particularly suitable for numerous clinicaltasks in hospitals, clinics and community care. It may alsobe used for many general purpose tasks as it conforms tothe basic health and safety requirements of the PPEDirective for minimal risk tasks.

Safe

Regular gauge

High grip microtextured surface

High comfort

High sensitivity

High tactility

Special advanced treatmentto improve donning andreduce leachable proteins

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Vinoguard®

Vinyl Gloves

Synthetic Premium Essentials

Page 26: Single Use Medical Examination Gloves · Vinyl is a synthetic polymer, more commonly known as polyvinyl chloride (PVC). To make the rigid polymer flexible and suitable for use as

Stretch Vinyl Gloves

Vinoguard® Synthetic is in a different league to most vinyl gloves. Think of vinyl gloves and often poorfitting, difficult to don, easy to rip gloves come to mind. This is not the case with Vinoguard® Synthetic,thanks to careful manufacturing and an improved formulation that delivers a superior vinyl glove. Thistype of glove is often referred to as pigmentised vinyl, as the glove has a creamy appearance unlike thetranslucent appearance of a standard vinyl glove.

Raising the bar on performance

Start to put on a Vinoguard® Synthetic glove and you willimmediately notice how it differs from standard, cheap vinylalternatives. Firstly the glove has a much softer and moreflexible feel. This makes donning significantly easier withouthaving to select a larger size than you would otherwiseneed, which would produce a baggy fit. Unlike standardvinyl, Synthetic also has improved stretch qualities that aidsthe donning process and feels more comfortable during use.The material stretches as you flex the hand and bendfingers, making manipulation of items much more naturaland minimising hand fatigue.

The performance benefits don’t end there. The formulationdelivers a higher strength glove that is more durable andoffers improved protection. If a glove rips easily, the barrierprotection is lost immediately. So a glove that maintains itsintegrity is safer to use. It is also more cost effective in thelong run as a damaged glove has to be replaced, addingadditional costs.

Feeling the quality

Gloves intended for medical examinations also need to offerthe user tactility and sensitivity of touch. Whilst not havingthe exceptional performance of nitrile and latex gloves,Vinoguard® Synthetic is an excellent and viable alternativewhere the clinical task is less critical, but still requires goodlevels of sensitivity and dexterity. This level of performanceis just not possible with standard vinyl gloves due to theirmore rigid construction. This is complemented by a smoothsurface finish, ideal for holding patients with fragile skinwithout causing pain.

Vinoguard® Synthetic is a Class l Medical Device that is acost conscious alternative to nitrile and latex gloves for lowrisk medical and general purpose tasks, particularly wherefrequent glove changes are required. Typically the glove issuitable for use in outpatient clinics, GP surgeries, nursingand care homes.

Vinoguard Synthetic®

AQL1.5

Technical Performance

Classification: Single use, Non sterile Class I Medical Device

Materials: Polyvinyl chloride; Does not contain latexDoes not contain styrene; Powder free

Design: Ambidextrous, smooth outer surface, beaded cuff

Inspection Criteria: AQL 1.5

Shelf Life: 3 years

Regulatory Principal legislation: Medical Devices Directive 93/42/EECCompliance: Other legislation: PPE Directive 89/686/EEC Minimal Risks

Product: EN 455-1; EN 455-2Production: ISO 13485; ISO 9001

Applications: Medical examination; routine patient care; care of the elderly; professional care in the home; nursing and care homes; general tasks

24

Vinoguard

® Synthetic

Advanced vinyl performance

Improved strength

Improved comfort

Improved sensitivity

Smooth finish

Latex Free

Cost conscious option

Product Code Size Gloves per Carton Unit of Sale

9590 Extra Small 100 10 Cartons9591 Small 100 10 Cartons9592 Medium 100 10 Cartons9593 Large 100 10 Cartons9594 Extra Large 100 10 Cartons

Page 27: Single Use Medical Examination Gloves · Vinyl is a synthetic polymer, more commonly known as polyvinyl chloride (PVC). To make the rigid polymer flexible and suitable for use as

Vinyl Gloves

All vinyl gloves are not made equal. Vinoguard® Premium offers the user a high quality alternativeto the many cheap vinyl gloves available today that just do not deliver on performance or realcost savings. Instead, Vinoguard® Premium is manufactured from a heavier, premium gauge ofpolyvinyl chloride (PVC) that delivers genuine improvements in performance at a cost consciousprice level.

Cost conscious – cost effective

When budgetary constraints dictate the use of a morecompetitively priced glove, Vinoguard® Premium is not foundwanting. Low unit purchasing costs do not automatically mean acost effective product. If more gloves have to be used becausethey rip easily on donning or puncture and tear during use, anycost savings are wiped out. This is where selecting Premiumpays dividend. Thanks to the premium vinyl grade used,Premium provides the purchasing team with savings whilst stillproviding the users with a glove that has good integrity and someets their needs for protection during general tasks, such asroutine patient care or cleaning work.

Premium is intended for low risk medical and generalapplications. The smooth surface finish makes it ideal for patientpersonal hygiene tasks, as the glove will not snag or grip whenwashing hair and skin. A glove with a high grip could causediscomfort for elderly patients who may have fragile skin, whenthey are being held or aided with mobility. In these situations,Vinoguard® Premium offers a superb alternative to nitrile andlatex gloves.

Making the grade on standards

Vinoguard® Premium is not only cost effective; it also doesnot compromise on quality standards. Premium fully conformsto the European harmonised product standards EN 455-1and EN 455-2: Medical Gloves for Single Use and is a Class lMedical Device (Medical Devices Directive 93/42/EEC) formedical examinations. It also conforms to the basic healthand safety requirements of the PPE Directive 89/686/EECfor minimal risks.

When you need a competitively priced vinyl glove that youcan be certain will deliver good performance and the assurancethat it meets the legal requirements and standards, make theinformed choice - Vinoguard® Premium.

Vinoguard Premium®

AQL1.5

Technical Performance

Classification: Single use, Non sterile Class I Medical Device

Materials: Polyvinyl chloride; Does not contain latexDoes not contain styrene; Powder free

Design: Ambidextrous, smooth outer surface, beaded cuff

Inspection Criteria: AQL 1.5

Shelf Life: 3 years

Regulatory Principal legislation: Medical Devices Directive 93/42/EECCompliance: Other legislation: PPE Directive 89/686/EEC Minimal Risks

Product: EN 455-1; EN 455-2Production: ISO 13485; ISO 9001

Applications: Medical examination; routine patient care; care of the elderly; professional care in the home; nursing and care homes; general tasks

25

Vinoguard

® Premium

Premium gauge

Smooth finish

Latex Free

Cost conscious

Product Code Size Gloves per Carton Unit of Sale

9585 Extra Small 100 10 Cartons9586 Small 100 10 Cartons9587 Medium 100 10 Cartons9588 Large 100 10 Cartons9589 Extra Large 100 10 Cartons

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Vinyl Gloves

In today’s economy, the push for savings is greater than ever. But care needs to be exercised toensure that the savings are genuine and legal requirements are not compromised. This is whereVinoguard® Essentials fits into the Readigloves® range. When cost is the prime concernEssentials offers a quality vinyl glove that genuinely complies with the Medical Devices Directiveand is a Class l Medical Device for medical examination use.

Regulatory compliance is not just an option

Vinoguard® Essentials is manufactured from a regular gaugeof polyvinyl chloride (PVC) and has been fully tested toconform to the European harmonised product standardsEN 455-1 and EN 455-2: Medical Gloves for Single Use.When selecting Essentials this compliance is backed upby the well established and trusted name of RobinsonHealthcare, for complete peace of mind that you arepurchasing a product that does what it says on the box.

This is an essential requirement to ensure the safety ofbarrier protection, preventing cross infection betweenclinician and patient. Cheap gloves are not cost effectiveif they have to be replaced due to poor integrity in use.Essentials is competitively priced without compromisingon delivering value during use.

Durable and smooth

Cheaper gloves are often made using a very light gaugeof PVC. This reduces their strength and durability. Try theweight test – compare the weight of Essentials with other,cheaper gloves and compare Essentials’ value for moneywith them. The regular gauge of Essentials performssignificantly better than lighter gloves as it has addedstrength and durability. Essentials last longer before needingto be changed and rip far less often during donning.Buying cheap really is a false economy.

The gloves have a smooth surface finish that is ideal forpatient personal hygiene tasks, as the glove will not snagor grip when washing hair and skin, or cause discomfort tofragile skin. It is also suitable for low risk medical andgeneral applications.

When you need a combination of competitive pricing,regulatory compliance and value for money, chooseVinoguard® Essentials.

Vinoguard Essentials®

AQL1.5

Technical Performance

Classification: Single use, Non sterile Class I Medical Device

Materials: Polyvinyl chloride; Does not contain latexDoes not contain styrene; Powder free

Design: Ambidextrous, smooth outer surface, beaded cuff

Inspection Criteria: AQL 1.5

Shelf Life: 3 years

Regulatory Principal legislation: Medical Devices Directive 93/42/EECCompliance: Other legislation: PPE Directive 89/686/EEC Minimal Risks

Product: EN 455-1; EN 455-2Production: ISO 13485; ISO 9001

Applications: Medical examination; routine patient care; care of the elderly; professional care in the home; nursing and care homes; general tasks

26

Vinogua

rd® Essen

tials

Regular gauge

Smooth finish

Latex Free

Cost conscious

Product Code Size Gloves per Carton Unit of Sale

9580 Extra Small 100 10 Cartons9581 Small 100 10 Cartons9582 Medium 100 10 Cartons9583 Large 100 10 Cartons9584 Extra Large 100 10 Cartons

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27

To request samples -

Tel: 01909 735010 or

Email: [email protected]

Please remember to include the following details:

The name of the glove you require; e.g. Nytraguard® Bluple®

The size(s) required e.g. Medium and Large

Your name and job role

Company name and address

A contact number (in case we have a question)

Robinson Healthcare offers a fast and efficient samples service.

Glove Sample Service

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28

Glo

ve S

ize

Gui

de

This sizing chart is provided for guidance only. Actual fit varies depending on the material and thickness(weight). To determine the most suitable size for any particular range of gloves, we recommend that youtrial samples of 2 or more sizes. For details of our Glove Sample Service, please see page 27.

Glove Size Guide

0 1

CM

2 3 4 5 6 7 8

Ext

ra S

mal

l

Sm

all

Med

ium

Larg

e

Ext

ra L

arg

e

9 10 11 12

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Co

ndit

ions

of

Sal

e

Conditions of sale

All goods are supplied subject to the company’s general conditionsof sale, which are available on request.

© Copyright 2013Robinson Healthcare Ltd.All rights reserved. No part of this publication may be reproduced,stored in a retrieval system or transmitted in any form or by any means,electronic, mechanical photocopying, recording or otherwise withoutprior permission of Robinson Healthcare Ltd.

Every care has been taken in compiling this catalogue. However, in theview of the possibility of typing, printing or other errors, the readershould not rely solely on the information contained herein.

Robinson Healthcare Ltd. operates a policy of continuous improvementand reserves the right to change, discontinue or modify the design andconstruction of any of its products and to substitute material equal toor superior to that originally specified.

Publication Ref: MEG01/13/5KMarch 2013

Page 32: Single Use Medical Examination Gloves · Vinyl is a synthetic polymer, more commonly known as polyvinyl chloride (PVC). To make the rigid polymer flexible and suitable for use as

Robinson Healthcare LtdLawn RoadCarlton-in-LindrickWorksopS81 9LBTel: +44 (0)1909 735000Email: [email protected]

www.robinsonhealthcare.com


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