ISO 10282:2023

INTERNATIONAL ISO
STANDARD 10282
Fourth edition
2023-02
Single-use sterile rubber surgical
gloves — Specification
Gants en caoutchouc à usage chirurgical, stériles, non réutilisables —
Spécifications
Reference number
© ISO 2023
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Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3  Terms and definitions . 1
4  Classification . 2
4.1 General . 2
4.2 Material . 3
4.3 Design . 3
4.4 Finish . 3
5 Materials . 3
6 Sampling and selection of test pieces . 4
6.1 Sampling . 4
6.2 Selection of test pieces. 4
7 Requirements . 4
7.1 Dimensions . 4
7.2 Watertightness . 5
7.3 Tensile properties . 5
7.3.1 General . 5
7.3.2 Force at break and elongation at break before accelerated ageing . 5
7.3.3 Force at break and elongation at break after accelerated ageing . 5
7.3.4 Force required to produce 300 % elongation . 6
7.4 Sterility . 6
8 Packaging. 6
9 Marking . . 6
9.1 General . 6
9.2 Inner package . 6
9.3 Unit package . 6
9.4 Multi-unit package . 7
Annex A (normative) Measurement of dimensions (width, length and thickness) .8
Annex B (normative) Test method for watertightness. 9
Bibliography .11
iii
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
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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).
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www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 45, Rubber and rubber products,
Subcommittee SC 4, Products (other than hoses).
This fourth edition cancels and replaces the third edition (ISO 10282:2014), which has been technically
revised.
The main changes are as follows:
— the previous Figures 1 and 2 have been replaced with Figure A.1;
— the powdered surface and powder-free surface have been updated;
— a statement on ageing gloves over six months old has been added;
— a new Annex A has been added and the previous Annex A has renamed to Annex B.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
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INTERNATIONAL STANDARD ISO 10282:2023(E)
Single-use sterile rubber surgical gloves — Specification
1 Scope
This document specifies requirements for packaged sterile rubber gloves intended for use in surgical
procedures to protect the patient and the user from cross-contamination.
This document is applicable to single-use gloves that are worn once and then discarded. It does not
apply to examination or procedure gloves.
This document covers gloves with smooth surfaces and gloves with textured surfaces over part or the
whole glove.
This document is intended to be 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 document.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. 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 23529, Rubber — General procedures for preparing and conditioning test pieces for physical test
methods
3  Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
powdered glove
glove where a powder has been added as a part of the manufacturing process, generally to facilitate
donning
3.2
powder-free glove
glove which has been manufactured without the deliberate addition of powdered materials to facilitate
donning
Note 1 to entry: Powder-free is also referred to as “powderless”, “no powder” or “non-powdered” or other words
to that effect.
3.3
lot
definite amount of some product, material or service, collected together
Note 1 to entry: An inspection lot may consist of several batches or parts of batches.
[SOURCE: ISO 2859-1:1999, 3.1.13]
3.4
lot size
number of items in a lot
[SOURCE: ISO 2859-1:1999, 3.1.14]
3.5
inspection level
index of the relative amount of inspection of an acceptance sampling scheme, chosen in advance, and
relating the sample size to the lot size
[SOURCE: ISO 3534-2:2006, 4.3.5, modified — Notes 1 and 2 to entry have been deleted.]
3.6
acceptance quality limit
AQL
quality level that is the worst tolerable process average when a continuing series of lots is submitted for
acceptance sampling
[SOURCE: ISO 2859-1:1999, 3.1.26, modified — Notes 1 and 2 to entry have been deleted.]
3.7
force at break
tensile stress recorded at the moment of rupture
[SOURCE: ISO 37:2017, 3.4, modified — the term has been modified from "tensile strength at break".]
3.8
elongation at break
tensile strain in the test length at breaking point
[SOURCE: ISO 37:20
...