Iso 10282-2014

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Spécifications
STANDARD
INTERNATIONAL
gloves — Specification
Single-use sterile rubber surgical
Gants en caoutchouc à usage chirurgical, stériles, non réutilisables —

10282
ISO
© ISO 2014
Reference number
Third edition
ISO 10282:2014(E)
2014-02-01
ISO 10282:2014(E)

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ii © ISO 2014 – All rights reserved

ISO 10282:2014(E)

Contents Page
Foreword......................................................................................................................................................................................................................................... iv
1 Scope.................................................................................................................................................................................................................................. 1
2 Normative references....................................................................................................................................................................................... 1
3 Classification............................................................................................................................................................................................................. 1
3.1 General............................................................................................................................................................................................................ 1
3.2 Type................................................................................................................................................................................................................... 1
3.3 Design.............................................................................................................................................................................................................. 2
3.4 Finish................................................................................................................................................................................................................ 2
4 Materials........................................................................................................................................................................................................................ 2
5 Sampling and selection of test pieces.............................................................................................................................................. 2
5.1 Sampling........................................................................................................................................................................................................ 2
5.2 Selection of test pieces...................................................................................................................................................................... 3
6 Requirements........................................................................................................................................................................................................... 3
6.1 Dimensions.................................................................................................................................................................................................. 3
6.2 Watertightness......................................................................................................................................................................................... 6
6.3 Tensile properties.................................................................................................................................................................................. 6
6.4 Sterility........................................................................................................................................................................................................... 7
7 Packaging...................................................................................................................................................................................................................... 7
8 Marking........................................................................................................................................................................................................................... 7
8.1 General............................................................................................................................................................................................................ 7
8.2 Inner package............................................................................................................................................................................................ 8
8.3 Unit package............................................................................................................................................................................................... 8
8.4 Multi-unit package................................................................................................................................................................................ 8
Annex A (normative) Test for watertightness.............................................................................................................................................. 9
© ISO 2014 – All rights reserved iii

ISO 10282:2014(E)

Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
patent rights identified during the development of the document will be in the Introduction and/or on
the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 45, Rubber and rubber products, Subcommittee
SC 4, Products (other than hoses).
This third edition cancels and replaces the second edition (ISO 10282:2002), of which it constitutes
a minor revision. It also incorporates the Technical Corrigendum ISO 10282:2002/Cor.1:2005 and the
following changes:
— addition of isoprene rubber latex as material for type 2 glove;
— only two finishes remain for classification, whereby powdered or powder-free finishes were deleted
and introduced in the note;
— addition on the applicability of the warning note to the unit package on the removal of surface-
dusting material prior to undertaking operative procedures.
iv © ISO 2014 – All rights reserved

INTERNATIONAL STANDARD ISO 10282:2014(E)
Single-use sterile rubber surgical gloves — Specification

1 Scope
This International Standard specifies requirements for packaged sterile rubber gloves intended for use
in surgical procedures to protect the patient and the user from cross-contamination. It is applicable to
single-use gloves that are worn once and then discarded. It does not apply to examination or procedure
gloves. It covers gloves with smooth surfaces and gloves with textured surfaces over part or the whole
glove.
This International Standard is intended as a reference for the performance and safety of rubber surgical
gloves. The safe and proper usage of surgical gloves and sterilization procedures with subsequent
handling, packaging, and storage procedures are outside the scope of this International Standard.
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.
ISO 37, Rubber, vulcanized or thermoplastic — Determination of tensile stress-strain properties
ISO 188, Rubber, vulcanized or thermoplastic — Accelerated ageing and heat resistance tests
ISO 2859-1, Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by
acceptance quality limit (AQL) for lot-by-lot inspection
ISO 10993 (all parts), Biological evaluation of medical devices
ISO 15223, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied
ISO 23529, Rubber — General procedures for preparing and conditioning test pieces for physical test methods
3 Classification
3.1 General
Gloves are classified by type, design, and finish, as given in 3.2 to 3.4.
3.2 Type
Two types are classified:
a) Type 1: gloves made primarily from natural rubber latex.
b) Type 2: gloves made primarily from nitrile rubber latex, isoprene rubber latex, polychloroprene
rubber latex, styrene-butadiene rubber solution, styrene-butadiene rubber emulsion or
thermoplastic elastomer solution.
© ISO 2014 – All rights reserved 1

ISO 10282:2014(E)

3.3 Design
Two designs are classified:
a) gloves with straight fingers;

b) gloves with fingers curved in the palmar direction.

The glove shall be anatomically correct, with the thumb positioned towards the palmar surface of
the index finger rather than lying flat. The fingers and thumb can be straight or curved in the palmar
direction.
3.4 Finish
Two finishes are classified:
a) textured surface over part or all of the glove;
b) smooth surface.
NOTE 1 Gloves can be powdered or powder-free. Powdered gloves are gloves where a powder has been added
as a part of the manufacturing process, generally to facilitate donning. Powder-free gloves are gloves which have
been manufactured without the deliberate addition of powdered materials to facilitate donning. Powder-free is
also referred to as “powderless”, “no powder” or “non-powdered” or other words to that effect.
NOTE 2 The cuff termination of the glove may be cut or in the form of a rolled rim.
4 Materials
Gloves shall be manufactured from compounded natural rubber or nitrile rubber or isoprene rubber or
polychloroprene rubber latex, or compounded styrene-butadiene rubber or thermoplastic elastomer
solution, or compounded styrene-butadiene rubber emulsion. To facilitate donning the gloves, any
surface treatment, lubricant, powder or polymer coating may be used subject to compliance with
ISO 10993.
Any pigment used shall be non-toxic. It is essential that substances used for surface treatment which are
capable of being transferred are bio-absorbable.
Gloves as supplied to the user shall comply with the relevant part(s) of ISO 10993. The manufacturer
shall make available to the purchaser, on request, data to support compliance with these requirements.
NOTE 1 Other suitable polymeric materials may be included in future editions of this International Standard.
NOTE 2 It is recognized that some individuals can, over a period of time, become sensitized to a particular
rubber compound (allergic reaction) and require gloves of an alternative formulation.
NOTE 3 Limits of extractable proteins, allergenic proteins, residual chemicals, endotoxins, and residual powder
in gloves may be specified in future editions of this International Standard, subject to the availability of relevant
ISO standard test methods.
5 Sampling and selection of test pieces
5.1 Sampling
For reference purposes, gloves shall be sampled and inspected in accordance with ISO 2859-1. The
inspection levels and acceptance quality limits (AQLs) shall conform to those specified in Table 1 for the
characteristics listed.
When a lot size cannot be determined, a lot of 35 001 to 150 000 shall be assumed.
2 © ISO 2014 – All rights reserved

ISO 10282:2014(E)

Table 1 — Inspection levels and AQLs

Characteristic Inspection leveI AQL
Physical dimensions (width, length, thickness) S-2 4,0

Watertightness G-I 1,5
Force at break and elongation at break (before and after accel- S-2 4,0
erated ageing) and force at 300 % elongation (before acceler-
ated ageing)
5.2 Selection of test pieces

Where test pieces are required, they shall be taken from the palm or back of gloves.
6 Requirements
6.1 Dimensions
When measured at the points shown in Figure 1, gloves shall comply with the dimensions for palm
width and length given in Table 2, using the inspection level and AQL given in Table 1.
The measurement of length shall be the shortest distance between the tip of the second finger and the
cuff termination.
NOTE The length measurement may be taken by hanging the glove on a suitable mandrel with a tip radius of
5 mm.
The measurement of width shall be at the midpoint between the base of the index finger and the base of
the thumb. The width measurement shall be made with the glove placed on a flat surface.
The thickness of the double wall of an intact glove shall be measured in accordance with ISO 23529, with
a pressure on the foot of 22 kPa ± 5 kPa at each of the locations shown in Figure 2: a point 13 mm ± 3 mm
from the extreme tip of the second finger, the approximate centre of the palm, and a point 25 mm ± 5 mm
from the cuff termination. The single-wall thickness at each point shall be reported as half the measured
double-wall thickness and shall comply with the dimensions given in Table 2, using the inspection level
and AQL given in Table 1.
If visual inspection indicates the presence of thin spots, then single-wall thickness measurements
shall be made in such areas. The thickness at the smooth area and textured area of a single wall when
measured as described in this subclause shall not be less than 0,10 mm and 0,13 mm respectively.
The thickness of the cuff termination measured in accordance with ISO 23529 should preferably not
exceed 2,50 mm.

4
ISO 10282:2014(E)

Figure 1 — Measurement points for width and length
© ISO 2014 – All rights reserved

ISO 10282:2014(E)

Table 2 — Dimensions and tolerances

Width Minimum length Minimum thickness
(dimension w, (dimension l, (at the locations shown

Size code
Figure 1) Figure 1) in Figure 2)
mm mm mm
5 67 ± 4 250
5,5 72 ± 4 250

6 77 ± 5 260
6,5 83 ± 5 260
For all sizes:
7 89 ± 5 270
Smooth area: 0,10
7,5 95 ± 5 270
Textured area: 0,13
8 102 ± 6 270
8,5 108 ± 6 280
9 114 ± 6 280
9,5 121 ± 6 280

ISO 10282:2014(E)

Dimensions in millimetres
NOTE The distance 48 mm ± 9 mm locates the approximate centre of the palm for different glove sizes.
Figure 2 — Measurement points for thickness
6.2 Watertightness
When gloves are tested for watertightness as described in Annex A, the sample size and allowable
number of non-conforming (leaking) gloves in the sample shall be determined in accordance with the
inspection level and AQL given in Table 1.
6.3 Tensile properties
6.3.1 General
Tensile properties shall be measured in accordance with ISO 37, taking three type 2 dumb-bell test
pieces from each glove and using the median value as the test result. Test pieces shall be taken from the
palm or back of gloves.

ISO 10282:2014(E)

6.3.2 Force at break and elongation at break before accelerated ageing
When determined in accordance with the method specified in ISO 37, using type 2 dumb-bell test pieces,
the force at break, force at 300 % elongation and elongation at break shall comply with the requirements
given in Table 3, using the inspection level and AQL given in Table 1.
Table 3 — Tensile properties

Requirement
Property
Type 1 glove Type 2 glove
Minimum force at break before accelerated ageing, N 12,5 9,0
Minimum elongation at break before accelerated ageing, % 700 600
Maximum force required to produce 300 % elongation before accelerated age-
2,0 3,0
ing, N
Minimum force at break after accelerated ageing, N 9,5 9,0
Minimum elongation at break after accelerated ageing, % 550 500
6.3.3 Force at break and elongation at break after accelerated ageing
Accelerated ageing tests shall be conducted in accordance with the method specified in ISO 188. After
the test pieces cut from the gloves have been subjected to a temperature of 70 °C ± 2 °C for 168 h ± 2 h,
the value of the force at break and the elongation at break shall comply with the requirements given in
Table 3, using the inspection level and AQL given in Table 1.
6.3.4 Force required to produce 300 % elongation
When determined in accordance with the method specified in ISO 37, using type 2 dumb-bell test pieces,
the force required to produce an elongation of 300 % shall comply with the requirements given in
Table 3, using the inspection level and AQL given in Table 1.
6.4 Sterility
Gloves shall be sterilized. The nature of the sterilization process shall be disclosed on request.
7 Packaging
Gloves shall be packaged in sequential two-layered packaging.
8 Marking
8.1 General
8.1.1 The marking shall include a reference to this International Standard. Appropriate international
symbols taken from ISO 15223 can be used for labelling.
8.1.2 The language used for marking shall be as agreed upon between the interested parties.
8.1.3 In the case of gloves that have been treated with any surface-dusting material, a warning note shall
be clearly marked on the inner package and/or unit package; to the effect that surface powder should be
aseptically removed prior to undertaking operative procedures.

ISO 10282:2014(E)

8.2 Inner package

Inner packages shall be clearly marked with the following:
a) the size;
b) the designation “left” or “L” or “right” or “R” on the package.

8.3 Unit package

The outer wrapping for each unit pair of gloves shall be clearly marked with the following:
a) the name or trademark of the manufacturer or supplier;
b) the material used;
c) the words “STRAIGHT FINGERS” or “CURVED FINGERS” or words to that effect for the appropriate
glove design;
d) the words “TEXTURED” or “SMOOTH”, “PRE-POWDERED” or “POWDER-FREE” or words to that
effect for the appropriate glove finish;
e) the size;
f) the manufacturer’s identifying lot number;
g) the words “DATE OF MANUFACTURE” or words to that effect, and the year in four digits and month
of manufacture;
h) the words “STERILE UNLESS THIS PACKAGE IS OPENED OR DAMAGED”;
i) the words “FOR SINGLE USE”;
j) the words “SURGICAL GLOVES”;
k) the words “Product is made from natural rubber latex which can cause allergic reactions” or words
to that effect for type 1 gloves.
8.4 Multi-unit package

A multi-unit package is one containing a predetermined number of unit packs of the same glove size,
intended to facilitate safe transport and storage. Multi-unit packages shall be marked in accordance
with 8.3 a), 8.3 b), 8.3 c), 8.3 d), 8.3 e), 8.3 f), 8.3 g), 8.3 i) and 8.3 j), with the words “xx pairs of surgical
gloves” and with the addition of instructions for storage.

ISO 10282:2014(E)

Annex A
(normative)
Test for watertightness

A.1 Apparatus
A.1.1 Circular hollow mandrel, of minimum external diameter 60 mm and adequate length to hold the
glove and, with the glove attached, to accommodate 1 000 cm3 of water. An example is given in Figure A.1.
NOTE It is useful if the mandrel is transparent.
A.1.2 Holding device, designed to hold the glove in vertical position when filled with water. An example
is given in Figure A.2.
A.1.3 Graduated cylinder, capacity at least 1 000 cm3 or other dispensing apparatus capable of
delivering 1 000 cm3 at a time.
A.2 Procedure
Attach the glove to the circular hollow mandrel by a suitable device, e.g. an O-ring, so that the glove does
not extend more than 40 mm over the mandrel.
Introduce 1 000 cm3 ± 50 cm3 of water at a maximum temperature of 36 °C into the device. Remove any
water that has inadvertently splashed on to the glove. If the water does not rise to within 40 mm of the
cuff end, raise the glove to ensure that the whole of the glove, excluding the part 40 mm from the cuff
end, is tested. Note any leaks immediately evident. If the glove does not leak immediately, make a second
observation for leaks 2 min to 4 min after pouring the water into the glove. Disregard leakage within
40 mm of the cuff end. To assist observation, the water can be coloured with a water-soluble dye.

10
Key
1 hook
2 cylinder
ISO 10282:2014(E)
3 score line on inside surface of wall

Figure A.1 — Mandrel

Dimensions in millimetres

Figure A.2 — Holding device
ISO 10282:2014(E)
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FREE LICENSE BY KENYA BUREAU OF STANDARDS (KEBS) TO INTERESTED PARTIES, STAKEHOLDERS

MANUFACTURERS AND PUBLIC, FOR A LIMITED ACCESS DURING COVID-19 EMERGENCY,

Gants en caoutchouc à usage chirurgical, stériles, non réutilisables —

COPYRIGHT PROTECTED DOCUMENT

ii ﻿ © ISO 2014 – All rights reserved

© ISO 2014 – All rights reserved ﻿ iii

iv ﻿ © ISO 2014 – All rights reserved

Single-use sterile rubber surgical gloves — Specification

© ISO 2014 – All rights reserved ﻿ 1

a) gloves with straight fingers;

b) gloves with fingers curved in the palmar direction.

5 Sampling and selection of test pieces

2 ﻿ © ISO 2014 – All rights reserved

Table 1 — Inspection levels and AQLs

Physical dimensions (width, length, thickness) S-2 4,0

5.2 Selection of test pieces

© ISO 2014 – All rights reserved ﻿ 3

© ISO 2014 – All rights reserved

Table 2 — Dimensions and tolerances

(dimension w, (dimension l, (at the locations shown

5,5 72 ± 4 250

© ISO 2014 – All rights reserved ﻿ 5

Figure 2 — Measurement points for thickness

6.3 Tensile properties

6 ﻿ © ISO 2014 – All rights reserved

6.3.2 Force at break and elongation at break before accelerated ageing

Table 3 — Tensile properties

6.3.3 Force at break and elongation at break after accelerated ageing

6.3.4 Force required to produce 300 % elongation

© ISO 2014 – All rights reserved ﻿ 7

8.2 Inner package

b) the designation “left” or “L” or “right” or “R” on the package.

8.3 Unit package

8.4 Multi-unit package

8 ﻿ © ISO 2014 – All rights reserved

Test for watertightness

© ISO 2014 – All rights reserved ﻿ 9

3 score line on inside surface of wall

© ISO 2014 – All rights reserved

© ISO 2014 – All rights reserved

Price based on 11 pages

© ISO 2014 – All rights reserved

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