GB/T 24786-2025 (GB 24786-2009) PDF English
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NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.140; 83.140.99
G 45
Single-use Medical Poly (vinyl chloride) Examination
Gloves
[ISO 11193-2.2006, Single-use Medical Examination Gloves - Part 2.
Specification for Gloves Made from Poly (vinyl chloride), MOD]
Issued on. DECEMBER 15, 2009
Implemented on. OCTOBER 1, 2010
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine;
Standardization Administration of the People’s Republic of
China.
Table of Contents
Foreword... 3
1 Scope... 4
2 Normative References... 4
3 Classification... 5
4 Materials... 5
5 Sampling and Selection of Test Pieces... 6
6 Requirements... 6
7 Packaging... 10
8 Marking... 10
Appendix A (normative) Water Impermeability... 13
Foreword
In this Standard, the content of Chapter 6 and 8.2 is mandatory; the remaining is
recommended.
This Standard adopts and modifies ISO 11193-2.2006 Single-use Medical Examination
Gloves - Part 2.Specification for Gloves Made from Poly (vinyl chloride), MOD (English
version).
This Standard was re-drafted in accordance with ISO 11193-2.2006.
In accordance with the domestic manufacturing technology of single-use medical poly
(vinyl chloride) examination gloves, this Standard makes the following technical
modifications.
---The breaking force index of single-use medical poly (vinyl chloride) examination
gloves before and after ageing is modified from 7.0 N (see 6.3.2 in ISO 11193-
2.2006) into 4.8 N (see Table 3).
For ease of use, this Standard has the same structure as ISO 11193-2.2006.In addition,
the following editorial modifications are made.
---The foreword of the previous international standard is deleted;
---The phrase “this International Standard” is modified into “this Standard”;
---Decimal point “.” is used to replace comma “,”, which is used as the decimal
point;
---“The language used for marking shall be as agreed upon between the interested
parties” in 8.1 is deleted.
In this Standard, Appendix A is normative.
This Standard was proposed by China Petroleum and Chemical Industry Association.
This Standard shall be under the jurisdiction of Latex Products Sub-Technical
Committee of National Technical Committee 35 on Rubber & Products of
Standardization Administration of China (SAC/TC 35 /SC 4).
The drafting organizations of this Standard. Shandong LANFAN Plastic Co., Ltd.;
Zhuzhou Rubber & Plastics Industry Research & Design Institute of China Rubber
Group; Beijing Institute of Medical Device Testing.
The main drafters of this Standard. Liu Wenjing, Zhang Yongchen, Deng Yizhi, Zhang
Xiaoli.
Single-use Medical Poly (vinyl chloride) Examination
Gloves
Warning. users of this Standard shall be familiar with normal laboratory
practices. This Standard does not involve any safety issues, even those related
to it are not an exception. Users shall establish corresponding safety and health
specifications; ensure the compliance with national regulations.
1 Scope
This Standard stipulates the requirements for non-sterile or packaged sterile poly (vinyl
chloride) gloves used to prevent cross infection between patients and users during
medical examination and diagnosis, or, the requirements for poly (vinyl chloride) gloves
used to prevent cross infection during treatment of patients. It also includes poly (vinyl
chloride) gloves used for the disposal of contaminated medical materials.
2 Normative References
Through the reference in this Standard, clauses of the following documents become
clauses of this Standard. In terms of references with a specific date, all the subsequent
modification sheets (excluding the corrected content) or the revised editions are not
applicable to this Standard.
3 Classification
Finished gloves are classified into the following types.
4 Materials
The gloves involved in this Standard shall be made of poly (vinyl chloride) materials.
For ease of wearing, surface treatment agents, lubricants, powders or polymer
coatings may be used.
5 Sampling and Selection of Test Pieces
For the purpose of arbitration, gloves shall be sampled and inspected in accordance
with the requirements in GB/T 2828.1.The inspection level and acceptance quality
limit (AQL) shall comply with the stipulations in Table 1.
6 Requirements
Tensile properties shall be determined in accordance with GB/T 528.From each glove,
cut 3 test pieces. Take the median as the result.
Sterilized gloves shall identify the type of sterilization as required.
7 Packaging
If gloves are sterilized, they shall be individually packed, or in pairs.
8 Marking
Unit package refers to a single glove or a pair of gloves being packed in a packaging
bag.
Appendix A
(normative)
Water Impermeability
The minimum diameter is 60 mm; it shall be able to hold 1,000 mL of water. In addition,
it shall have sufficient length to fix the gloves, as it is shown in Figure A.1.
...... Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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