GB/T 7543-2020Single-use sterile rubber surgical gloves (English PDF)

Foreword

This Standard was drafted in accordance with the rules given in GB/T 1.1-2009.

This Standard replaces GB 7543-2006 "Single-use sterile rubber surgical gloves -

Specification". Compared with GB 7543-2006, in addition to the editorial

modifications, the main technical changes in this Standard are as follows.

- In the Scope, modified "This Standard specifies the technical requirements for

packaged sterile rubber gloves used in surgical procedures to protect the patient

and user and avoid cross-contamination. It is applicable to disposable gloves that

are worn once and then discarded. It is inapplicable to examination gloves or

procedure gloves. It includes gloves with smooth surfaces and gloves with hemp

surfaces. " TO "This 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." (see Chapter 1 of this Edition, Chapter 1 of Edition 2006);

- In 3.2 Type, modified "b) Type 2.gloves manufactured primarily from nitrile rubber

latex, neoprene latex, styrene-butadiene rubber latex, styrene-butadiene rubber

latex or thermoplastic elastomer solution." TO "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." (see 3.2 of this Edition, 3.2 of Edition 2006);

- in 3.4 Finish, modified "There are four types of finishes. a) pockmarked surface; b)

smooth surface; c) powdered surface; d) powder-free surface." TO "Two finishes

are classified. a) textured surface over part or all of the glove; b) smooth surface."

(see 3.4 of this Edition, 3.4 of Edition 2006);

- in Chapter 4, modified "Gloves are made with natural rubber latex, nitrile rubber

latex, neoprene latex, styrene-butadiene rubber or thermoplastic elastomer

solution, or styrene-butadiene rubber latex. For ease of donning, surface treatment

with ISO 10993 compliant lubricants, powders or polymeric coatings may be

used." TO "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." (see Chapter 4 of this Edition, Chapter 4 of Edition

2006);

- in 6.3.1, modified "Tensile properties shall be determined in accordance with ISO

37 Cut 3 test pieces from each glove. The result is the median value. The test

piece should be taken from the palm or back of the glove." TO "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." (see 6.3.1 of this Edition, 6.3.1

of Edition 2006).

This Standard uses translation method to identically adopt ISO 10282.2014 "Single-use

sterile rubber surgical gloves - Specification".

The Chinese documents which have consistency with the international normative

references in this Standard are as follows.

- GB/T 528-2009, Rubber, vulcanized or thermoplastic - Determination of tensile

stress-strain properties (ISO 37.2005, IDT)

- GB/T 2828.1-2012, Sampling procedures for inspection by attributea-Part1.

Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot

inspection (ISO 2859-1.1999, IDT)

- GB/T 2941-2006, Rubber - General procedures for preparing and conditioning test

pieces for physical test methods (ISO 23529.2004, IDT)

- GB/T 3512-2014, Rubber, vulcanized or thermoplastic - Accelerated ageing and

heat resistance tests (ISO 188.2011, IDT)

- GB/T 16886 (all parts), Biological evaluation of medical devices [ISO 10993(all

parts)]

- YY/T 0466.1-2016, Medical devices - Symbols to be used with medical device

labels, labelling and information to be supplied - Part 1.General requirements

(ISO 15223.2012, IDT)

This Standard was proposed by China Petroleum and Chemical Industry Federation.

This Standard shall be under the jurisdiction of National Technical Committee on

Rubber and Rubber Products of Standardization Administration of China (SAC/TC 35).

The drafting organizations of this Standard. Shanghai Kebang Medical Latex

Equipment Co., Ltd., Medikang Medical Products Trading (Shanghai) Co., Ltd., Anhui

Hejia Medical Products Technology Co., Ltd., Guilin Zizhu Latex Products Co., Ltd.,

Xishuangbanna Yunmeng Xinxing Natural Rubber Co., Ltd., Shanghai Zhimei Rubber

Co., Ltd., Shanghai Huaxin Medical Materials Co., Ltd., Huaxin Medical Materials

(Anhui) Co., Ltd., Anhui Food and Drug Inspection and Research Institute, National

Health Commission Science and Technology Research Institute, National Latex

Product Quality Supervision and Inspection Center, Anhui Zhongzhike Standardization

Institute Co., Ltd., Blue Sail Medical Co., Ltd., Xinjiang Uygur Autonomous Region

Drug Inspection and Research Institute, Jiangxi Hengsheng Industrial Co., Ltd.,

Shaanxi Provincial Medical Device Quality Supervision and Inspection Institute,

Dongguan Jingan New Materials Co., Ltd., Guangdong Shunde Chuangke Testing

Technology Co., Ltd. Company, China National Chemical Zhuzhou Rubber Research

and Design Institute Co., Ltd.

Main drafters of this Standard. Zhu Xiaohua, Fan Yao, Hu Jun, Luo Jinhui, Zhang

Bohou, Ma Jinfeng, Jiang Jiming, Liu Junqiang, Li Jianbin, Wu Yebin, Zheng Tiankun,

Zheng Kaiwen, Zheng Kaiyuan, Huang Baohua, Ning Lifeng, Li Peng, Tan Yunhua,

Cui Congjun, Liu Wenjing, Liu Wei, Zhu Yizhong, Mei Wenbin, Zhang Cheng, Huang

Weihua, Zhang Jianxin, Deng Yizhi, Wang Jinying.

Versions of standard substituted by this Standard are.

- GB 7543-1987, GB 7543-1996, GB 7543-2006.

Single-use sterile rubber surgical gloves

1 Scope

This 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.

2 Normative references

The following referenced documents are indispensable for the application 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.

3 Classification

Two types are classified.

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.

5 Sampling and selection of test pieces

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.

6 Requirements

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.

7 Packaging

Gloves shall be packaged in sequential two-layered packaging.

8 Marking

The outer wrapping for each unit pair of gloves shall be clearly marked with the

following.

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.

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