Medical gloves for single use - Guidance for selection

This Technical Report provides information for those choosing or using sterile and non-sterile gloves for medical applications based on a risk assessment. It deals with gloves worn primarily for the protection of the patient and glove user from biological cross contamination.
NOTE   Gloves worn specifically for the protection of the glove user from e.g. chemical and biological hazards are covered by the EU-Directive on Personal Protective Equipment (PPE) and the related standards e.g. EN 16523-1, EN 374-2, EN 374-4, EN ISO 374-1 and EN ISO 374-5.
This document describes the rationale behind the requirements of the EN 455 series and explores the possible trade-offs in glove selection between the various factors which affect glove, physical properties, biocompatibility, comfort and sensitivity. The strengths and weaknesses of various alternative glove materials and the potential biological hazards presented by their use are also explored.

Medizinische Einmalhandschuhe - Leitlinien für die Auswahl

Gants médicaux non réutilisables - Lignes directrices pour sélectionner des gants médicaux non réutilisables

Medicinske rokavice za enkratno uporabo - Smernice za izbiro

To tehnično poročilo podaja informacije za tiste, ki izbirajo ali uporabljajo sterilne in nesterilne rokavice za medicinsko uporabo na podlagi ocene tveganja. Obravnava rokavice, ki se nosijo predvsem za zaščito bolnika in uporabnika rokavic pred biološko navzkrižno kontaminacijo.
OPOMBA: Rokavice, ki se nosijo izključno za zaščito uporabnika rokavic pred npr. kemičnimi in biološkimi nevarnostmi, so zajete v direktivi EU o osebni zaščitni opremi (PPE) in povezanih standardih npr. EN 16523 1, EN 374-2, EN 374-4, EN ISO 374-1 in EN ISO 374-5.
Ta dokument opisuje utemeljitev za zahteve v skupini standardov EN 455 in preučuje možne kompromise pri izbiri rokavic v povezavi z različnimi dejavniki, ki vplivajo na rokavice, kot so fizične lastnosti, biološka združljivost, udobje in občutljivost. Preučene so tudi prednosti in pomanjkljivosti različnih alternativnih materialov za rokavice in morebitne biološke nevarnosti zaradi njihove uporabe.

General Information

Status
Published
Publication Date
14-Nov-2017
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
15-Nov-2017
Completion Date
15-Nov-2017

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SLOVENSKI STANDARD
SIST-TP CEN/TR 16953:2018
01-januar-2018
Medicinske rokavice za enkratno uporabo - Smernice za izbiro medicinskih rokavic
za enkratno uporabo
Medical gloves for single use - Guidance for selection
Medizinische Einmalhandschuhe - Leitlinien für die Auswahl

Gants médicaux non réutilisables - Lignes directrices pour sélectionner des gants

médicaux non réutilisables
Ta slovenski standard je istoveten z: CEN/TR 16953:2017
ICS:
11.140 Oprema bolnišnic Hospital equipment
13.340.40 Varovanje dlani in rok Hand and arm protection
SIST-TP CEN/TR 16953:2018 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TP CEN/TR 16953:2018
CEN/TR 16953
TECHNICAL REPORT
RAPPORT TECHNIQUE
November 2017
TECHNISCHER BERICHT
ICS 11.140
English Version
Medical gloves for single use - Guidance for selection

Gants médicaux non réutilisables - Lignes directrices Medizinische Einmalhandschuhe - Leitlinien für die

pour sélectionner des gants médicaux non réutilisables Auswahl

This Technical Report was approved by CEN on 22 October 2017. It has been drawn up by the Technical Committee CEN/TC 205.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TR 16953:2017 E

worldwide for CEN national Members.
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Contents Page

European foreword ....................................................................................................................................................... 4

Introduction .................................................................................................................................................................... 5

1 Scope .................................................................................................................................................................... 6

2 Normative references .................................................................................................................................... 6

3 Terms and definitions ................................................................................................................................... 6

4 Considerations in glove selection.............................................................................................................. 8

4.1 General ................................................................................................................................................................ 8

4.2 Cross contamination risk ............................................................................................................................. 9

4.2.1 General ................................................................................................................................................................ 9

4.2.2 Freedom from holes ....................................................................................................................................... 9

4.2.3 Physical properties ...................................................................................................................................... 10

4.2.4 Storage stability ............................................................................................................................................ 10

4.3 Biocompatibility ........................................................................................................................................... 11

4.3.1 General ............................................................................................................................................................. 11

4.3.2 Allergenic potential ..................................................................................................................................... 11

4.3.3 Plasticisers...................................................................................................................................................... 13

4.4 Potential contaminants .............................................................................................................................. 13

4.4.1 General ............................................................................................................................................................. 13

4.4.2 Glove Powder ................................................................................................................................................. 13

4.4.3 Sterilisation residues (Endotoxins) ....................................................................................................... 14

4.4.4 Surface additives .......................................................................................................................................... 14

5 Raw materials ................................................................................................................................................ 14

5.1 Specific glove raw materials..................................................................................................................... 14

5.1.1 Natural rubber .............................................................................................................................................. 14

5.1.2 Synthetic rubber ........................................................................................................................................... 14

5.1.3 Thermoplastics ............................................................................................................................................. 14

5.2 Glove coating .................................................................................................................................................. 14

6 Glove disinfection......................................................................................................................................... 15

7 Labelling .......................................................................................................................................................... 15

Annex A (informative) Glove materials and their use ................................................................................. 16

Annex B (informative) Additional information .............................................................................................. 18

B.1 Double gloving ............................................................................................................................................... 18

B.2 Food contact ................................................................................................................................................... 18

B.3 Handling chemicals and chemotherapy drugs .................................................................................. 18

B.4 Effects of creams or disinfectants on medical gloves ...................................................................... 18

B.5 Classes of medical gloves ........................................................................................................................... 19

B.6 Sharp EU-Directive (2010/32/EEC)....................................................................................................... 19

B.7 Cytotoxicity of medical gloves ................................................................................................................. 19

B.8 Glove selection, use time and durability .............................................................................................. 19

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B.9 Use of sterile examination vs. sterile surgical gloves ...................................................................... 20

Annex C (informative) CE-Marking ...................................................................................................................... 21

Bibliography ................................................................................................................................................................. 22

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European foreword

This document (CEN/TR 16953:2017) has been prepared by Technical Committee CEN/TC 205 “Non-

active medical devices”, the secretariat of which is held by DIN.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

This document has been prepared under a mandate given to CEN by the European Commission and the

European Free Trade Association.

This Technical Report gives information for use in the EN 455 series of standards. EN 455, Medical

gloves for single use, which consists of the following parts:
— Part 1: Requirements and testing for freedom from holes
— Part 2: Requirements and testing for physical properties
— Part 3: Requirements and testing for biological evaluation
— Part 4: Requirements and testing for shelf life determination
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Introduction

This Technical Report sets out guidance for users and choosers for selection, storage and use of gloves

for medical applications.

Glove selection is technically complex and should be undertaken by suitably qualified professionals.

Medical gloves have been shown to be a barrier to agents responsible for the transmission of infections.

In order to help ensure effectiveness, it is essential that the gloves fit properly, are free from holes, and

have adequate physical properties over their entire shelf life to resist barrier failure during use. In

addition it is important that adequate information is provided on any risks to the health of glove users

or patients that use of the gloves can cause, e.g. allergic reactions. These issues are addressed in the

EN 455 series.

EN Standards once mandated by the EU Commission are referred to as ‘harmonized’ and are binding on

CEN Member States. Products which comply with harmonized standards are assumed to comply with

relevant Essential Requirements. ‘Horizontal’ standards apply across a range of different types of

product (e.g. sterility or labelling). ‘Vertical’ standards apply to a specific type of product e.g. medical

gloves.

CE marking is a key indicator of a product’s compliance with EU legislation and enables the free

movement of products within the European market. By affixing the CE marking on a product, a

manufacturer is declaring conformity with all legal requirements to achieve CE marking and therefore

ensuring validity for that product to be sold throughout the EEA, the member states of the EU and

European Free Trade Association countries - Iceland, Norway, Liechtenstein and Turkey. Further

information regarding CE marking can be found in Annex C.

Single-use medical gloves fall into two main device classifications depending on degree of invasiveness

of their use.

Non sterile Examination gloves are class I medical devices and are CE marked by the manufacturer

without third party regulatory approval. They are usually, but not necessarily, ambidextrous and bulk-

packed. Sterile examination gloves are class I sterile medical devices designed for short non-invasive

aseptic procedures (generally less than 60 min) in patient care. They require regulatory approval for

their sterility. Because they are intended for short procedures only, examination gloves are generally

thinner, and less robust than surgical grade gloves. They are usually sold in a limited number of sizes.

The force at break requirements for such gloves are specified at levels which are lower than for surgical

gloves but are based on many years cumulative experience of minimum requirements needed to ensure

acceptable performance in use. Values differ for different materials and are reflected in the

requirements of EN 455-2. They are sold either powdered with donning powder or as ‘powder free’.

Powder free gloves may have surface treatments or added chemical agents to assist in easy donning.

Surgical gloves are class IIa medical devices and are designed for invasive procedures. CE marking

requires approval of a Notified Body. They are sold sterile in a range of full and half sizes and packed in

pairs of handed gloves. Packaging is normally in an easy peel pack that can deliver sterile inner

wrapped gloves onto the sterile surgical field. Sterility is achieved by e.g. gamma or electron beam

irradiation or by ethylene oxide treatment. Surgical gloves are sterilized to a sterility assurance level

(SAL) of 10 (according to EN 556-1) which gives a one in a million probability of finding a non sterile

device. Force at break requirements are more rigorous than for examination gloves and reflect the

levels that can be achieved for the materials concerned balanced against other in-use factors such as

comfort, dexterity and sensitivity of touch.
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1 Scope

This Technical Report provides information for those choosing or using sterile and non-sterile gloves

for medical applications based on a risk assessment. It deals with gloves worn primarily for the

protection of the patient and glove user from biological cross contamination.

NOTE Gloves worn specifically for the protection of the glove user from e.g. chemical and biological hazards

are covered by the EU-Directive on Personal Protective Equipment (PPE) and the related standards e.g. EN 16523-

1, EN 374-2, EN 374-4, EN ISO 374-1 and EN ISO 374-5.

This document describes the rationale behind the requirements of the EN 455 series and explores the

possible trade-offs in glove selection between the various factors which affect glove, physical

properties, biocompatibility, comfort and sensitivity. The strengths and weaknesses of various

alternative glove materials and the potential biological hazards presented by their use are also

explored.
2 Normative references

The following documents, in whole or in part, are normatively referenced in this document and are

indispensable for its application. For dated references, only the edition cited applies. For undated

references, the latest edition of the referenced document (including any amendments) applies.

EN 455 (series), Medical gloves for single use

EN ISO 374-5, Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology

and performance requirements for micro-organisms risks (ISO 374-5)

EN ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin

sensitization (ISO 10993-10)

ISO 2859-1, Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by

acceptance quality limit (AQL) for lot-by-lot inspection
3 Terms and definitions

For the purposes of this document, the terms and definitions given in the EN 455 series and the

following apply.
3.1
EU Directives
3.1.1
MDD
MD Directive
(Medical Device Directive)

legal act of the European Union covering the requirements that apply to medical devices including

gloves with a medical purpose in the patient environment

Note 1 to entry: Protection against chemicals such as disinfectants, chemotherapy drugs etc. or against

mechanical risks is not considered to be a medical purpose.

Note 2 to entry: Prior to amendment by Directive 2007/47/EC, MD Directive did not apply to personal

protective equipment covered by Directive 89/686/EEC. The principal intended purpose of the product was

decisive for deciding whether either the PPE Directive or the MD Directive was applicable.

Note 3 to entry: The interpretative document of the European commission's services of August 2009 clarifies

that products for which a manufacturer claims a double purpose (MD and PPE) are covered by the MD Directive.

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In case of simultaneous application of MDD and PPE Directives the product need to undergo the conformity

assessment procedures of both directives.

Note 4 to entry: The MDD will be superseded by the upcoming MDR (Medical Devices Regulation). For further

information see www.eur-lex.europa.eu .
3.1.2
PPED
PPE Directive
(Personal Protective Equipment Directive)

legal act of the European Union covering the requirements that apply to any device worn or held by an

individual for protection against one or more health and safety hazard

Note 1 to entry: PPE Directive covers only the safety of the glove user rather than the patient.

Note 2 to entry: Only a CE-mark approved by a notified body ensures compliance to PPE Directive category II

and III.

Note 3 to entry: The Directive 89/686/EEC will be superseded by the PPER (Personal Protective Equipment

Regulation 2016/425). For further information see http://eur-lex.europa.eu/homepage.html

3.2
single-use medical gloves
device intended to be used once only for a single patient
3.3
elastomer/elastic polymer

macromolecular material which returns rapidly to approximately its initial dimensions and shape after

substantial deformation by a weak stress and release of the stress
[SOURCE: ISO 1382:2012 modified, the heading “/elastic polymer” was added]
3.4
specific glove raw materials
3.4.1
natural rubber

solid material with elastic properties obtained from the botanic source Hevea brasiliensis

Note 1 to entry: Cis-1,4-polyisoprene is the main constituent of NR.
[SOURCE: EN 923:2015, 2.3.15]
3.4.2
synthetic rubber

manufactured elastomeric material which in comparison to natural rubber, may have varying degrees

of elasticity and hardness
Note 1 to entry: For further information see 5.1.2.
3.4.3
thermoplastics

plastics that are capable of being repeatedly softened by heating and hardened by cooling through a

temperature range characteristic of the plastics and, in the softened state, of being repeatedly shaped by

flow into articles by moulding, extrusion or forming
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3.4.4
latex
colloidal aqueous dispersion of a polymeric material
[SOURCE: EN ISO 472:2013, 2.529]

Note 1 to entry: This may be naturally occurring as in e.g. natural rubber latex, the milky extract from the

rubber plant, or may be manufactured, as in dispersions of synthetic polymers in water, e.g. polychloroprene latex,

or as in latex paints which are pigments bound by polymeric resins dispersed in water. The term “latex glove” is

commonly understood to refer to natural rubber gloves but it can also apply to synthetic rubber gloves as these

are produced from a latex. There is therefore potential for misinterpretation.
4 Considerations in glove selection
4.1 General

Those wishing to select medical gloves for specific procedures will do so, on the basis of a risk

assessment of the potential hazards to patient and glove user.
The risk assessment will include:
— the risks associated with cross contamination (see 4.2);
— the length of the procedure/comfort/durability required;

— degree of manual dexterity envisaged e.g. procedures where thicker gloves or/and double gloving

is recommended to provide added protection will be at the expense of reduced sensitivity and

comfort. Micro surgery may require a thinner glove affording greater sensitivity at the expense of

durability;

— physical challenge of the procedure to the glove material e.g. handling sharp or potentially

damaging instruments/materials; and

— biocompatibility issues, i.e. the potential for allergic reaction by the glove user or patient and risk of

contamination of either by extractable/leachable glove components (see 4.3).
The following hazards are addressed by the EN 455 series:
— biological organism material (fungi, bacteria, viruses);
— non biocompatibility.
The following hazards are not addressed by the EN 455 series:

— chemical permeation or degradation e.g. by disinfectants or chemotherapy drugs;

— physical and mechanical damage e.g. by sharp instruments, needles.

Gloves that offer protection against the above hazards should comply with the PPE Directive and the

related standards e.g. EN 16523-1, EN 374-2, EN 374-4, EN ISO 374-1 and EN ISO 374-5. Medical gloves

required to perform this additional function should conform to the relevant PPE Directive and related

standards.

Guidance for selection of gloves with respect to the intended use and risk is given in Figure 1. Where

conformity with more than one directive is claimed this will be indicated by the affixing of the CE mark

with reference to the relevant directives.
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Additional information can be found in Annex B.

Figure 1 — Guidance for selection of gloves with respect to the intended use and risk

4.2 Cross contamination risk
4.2.1 General

The risk of cross contamination between medical glove user and patient varies with factors such as:

infection status of patient, degree of exposure to body fluids, status of patient immune system, degree of

invasiveness of procedure, barrier effectiveness of gloves, length of procedure, likelihood of physical

damage to gloves etc.. These factors should be included in the risk assessment procedure to choose an

appropriate glove material and properties.

Any glove material is required to be tested to confirm that it is a barrier to microorganisms (bacteria,

viruses, fungi). This is confirmed by the bacteriophage test as described in EN ISO 374-5 or equivalent

(e.g. ASTM F1671-08). The effective barrier properties of any finished glove will be dependent on the

glove being intact and this is dependent on the quality of its manufacture (freedom from holes, physical

properties). These two factors are covered by EN 455-1 and EN 455-2.
4.2.2 Freedom from holes

Only an intact film will act as a barrier to microorganisms. Consequently, testing for freedom from holes

is an appropriate test to demonstrate barrier properties to microorganisms including viruses.

Requirements and testing for freedom from holes is considered in EN 455-1 which describes the testing

necessary to establish the required degree of freedom from holes as measured by a water tightness test.

The water tightness test is the reference test for detection of holes.

NOTE 1 A manufacturer's claim of 100 % air inflation testing is only of value if accompanied by visual

inspection to detect imperfections which could lead to rapid hole formation on extension, e.g. bubbles in finger

crotches. Tiny holes in areas which do not stretch greatly with air inflation will not be detected by this test. Any

claim based on electronic testing akin to that used in condom quality assurance is also not reliable due to

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difficulties in maintaining close contact between all parts of the glove and the electrically conducting former. This

means that holes in remote parts of the glove can go undetected.

Due to the nature of the manufacturers dipping process for elastomeric gloves it is not possible to

guarantee complete freedom from holes. The only course open to the manufacturer is therefore to take

a statistically representative sample of gloves and measure how many holes are present. Each

production lot is sampled according to ISO 2859-1 (Sampling Procedures for Inspection by Attributes)

with specified limits on sample size. The maximum level of holes allowed for compliance with ISO 2859-

1 is an Acceptance Quality Limit (AQL) of 1,5. This level was arrived at as being achievable in practice

without incurring undue consumer risk. Manufacturers wishing to consistently achieve this AQL with

minimized risk of failure will strive to maintain a process average for holes of consistently less than this.

Some manufacturers may be able to fine tune their manufacturing process to a level where they achieve

a lower AQL for holes and make a claim accordingly, e.g. AQL for holes of 1,0 or 0,65. Any such claim

needs to be fully supported by valid statistical data.

NOTE 2 AQL stands for “Acceptance Quality Limit” and is defined as the “quality level that is the worst

tolerable” in ISO 2859-1. It specifies the maximum number of defective units, beyond which a batch is rejected.

EN 455-1 only applies to product before use during shelf life. However it says nothing about the likelihood of holes

forming in the gloves during use. The duration of use of any particular glove will depend on the procedure and the

result of the risk assessment.
4.2.3 Physical properties
Requirements for physical properties of gloves are considered in EN 455-2.

EN 455-2 describes methods for measurement of a range of physical properties of medical gloves from

dimensions (length, width, thickness) to physical strength. It defines minimum median values for length

and force at break and median ranges for palm width, measured on 13 samples per lot.

Strength measurements are made on samples taken from the palm region of the glove so in order to

ensure that the required material strength is achieved at the glove finger tips a correction factor has to

be applied if thickness differs between the two regions by greater than 10 %. Values required differ

between natural and synthetic and elastomeric and thermoplastic materials but are generally based on

historical experience of what is achievable as representative of a well manufactured product and shown

to provide satisfactory in-use performance for each material.

The choice of glove for a particular procedure will be made on a variety of factors considered in the risk

assessment process.

Annex A summarizes the relative material properties of the commonly used glove materials.

4.2.4 Storage stability

Before products are placed on the market manufacturers are required to carry out accelerated stability

testing to estimate the product shelf life. And as part of the required post market surveillance

procedures, they are also required to initiate real time stability tests to confirm or extend the stated

shelf life.

The procedures to be followed in establishing and supporting the product shelf life are outlined in

EN 455-4. Accelerated testing involves storage at elevated temperatures for short periods and

extrapolating quantitative changes with time and temperature to shelf life at 25 °C. Measurements are

made of all properties which might reasonably be expected to change over the shelf life of the product.

These properties include but are not limited to, force at break, freedom from holes and, in the case of

sterile gloves, pack integrity. EN 455-4 requires that these tests are conducted on new products and on

any existing product where there has been any significant change in formulation or manufacturing

process.
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For product that is less than 12 months old it is a requirement of EN 455-2 that physical properties

remain in excess of the minimum requirements even after challenge testing for 7 days at 70 °C.

EN 455-4 requires that all medical gloves meet the requirements of EN 455 series throughout their

shelf-life.

To ensure that medical gloves will safely achieve their predicted shelf life manufacturers usually make

recommendations on long term storage of their products which usually include, dry conditions, above

e.g. 5 °C, below 30 °C or 25 °C and avoidance of direct sunlight, ozone or other sources of heat or

irradiation.
4.3 Biocompatibility
4.3.1 General
Biocompatibility issues are addressed in EN 455-3.

EN 455-3 was initiated in response to reports of adverse reactions to proteins in natural rubber latex

products which became prevalent in the late 1980s early 1990s. It also considers adverse reactions due

to other factors ranging from residual chemicals to lubricants to bacterial residues (endotoxins), after

sterilization.
4.3.2 Allergenic potential
4.3.2.1 General

The potential allergens present in medical gloves range from residual protein in natural rubber

products to residual chemicals used in the crosslinking process of sulphur cured elastomers, both

natural and synthetic.
Several factors contribute to the risk of reaction:
a) Type and level of allergens present in the glove;
b) the duration and frequency of skin contact with gloves;
c) the occlusive nature of the glove/skin interaction during glove use;
d) the manner of exposure to the allergens (skin, mucosa, tissue and inhalati
...

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