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GB 10213-2006 English PDF (GB10213-2006)

GB 10213-2006 English PDF (GB10213-2006)

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GB 10213-2006: Single-use medical rubber examination gloves

GB 10213-2006
ICS 83.140
G 44
GB
National Standard
of the People’s Republic of China
GB 10213-2006 / ISO 11193.1.2002
Replacing GB 10213-1995
Single-use medical rubber examination gloves
(ISO 11193.1.2002 Single-use medical rubber examination gloves - Part 1. Specification for gloves made from rubber latex or rubber solution, IDT) ISSUED ON. MARCH 14, 2006
IMPLEMENTED ON. DECEMBER 1, 2006
Issued by. General Administration of Quality Supervision, Inspection and Quarantine;
Standardization Administration Committee.
Table of Contents
Foreword 3
1 Scope 5
2 Normative references .. 5
3 Classification 6
4 Materials 7
5 Sampling and selection of test pieces . 7
6 Requirements .. 8
7 Packaging 12
8 Signs .. 13
Appendix A 15
Foreword
The content of Chapter 6 of this Standard is mandatory, the rest are
recommended.
This Standard is equivalent to adopt ISO 11193.1.2002 "Single-use rubber medical examination gloves - Part 1. Specification for gloves made from rubber latex or rubber solution" (English version).
For ease of use, this Standard only makes editorial changes to ISO
11193.1.2002.
This Standard replaces GB 10213-1995 "Single-use rubber examination
gloves".
This Standard is equivalent to translating ISO 11193.1.2002.
The main differences between this Standard and GB 10213-1995 are as follows. - MODIFY the name of Standard;
- ADD the content of glove classification (shown in Chapter 3);
- ADD that the material making glove is synthetic rubber latex and solution (Chapter 3 of 1995-edition; Chapter 4 of this edition);
- The inspection level of impermeability is revised from "S-4" to "G-I" (shown in Table 1); - The dimension of glove is revised from large, medium and small TO extra small, small, medium, large and extra large. ADD seven models of which the dimension codes are 6 and below, 6.5, 7, 7.5, 8, 8.5, 9 and above (shown in Table 2); - The original tensile strength is revised to be breaking tenacity. The requirements for different tensile property of different types of gloves are different (shown in Table 3).
The Appendix A of this Standard is normative.
This Standard was proposed by China Petroleum and Chemical Industry
Association.
This Standard shall be administrated by Technical Committee of Latex
Products of National Standardization Technical Committee of Rubber and
Rubber Products (SAC/TC 35/SC 4).
Main drafting organization of this Standard. Zhuzhou Industry Research and Design Institute of Rubber and Plastics of China Rubber Group.
Main drafter of this Standard. Zhao Ping.
The previous versions replaced by this Standard are.
- GB 10213-1988, GB 10213-1995.
Single-use medical rubber examination gloves
1 Scope
This Standard specifies the requirements for the rubber examination gloves that are sterilized or non-sterilized, and that are used to prevent cross-infection between patients and users in the process of medical examination and
diagnostic treatment. It also includes rubber examination gloves used to process contaminated medical materials. The surface of glove is smooth or pitted.
This Standard specifies the requirements for the property and safety of rubber examination gloves. However, the safety inspection, proper use, sterilization process, subsequent treatment, and storage process of gloves are not within the scope of this Standard.
2 Normative references
The provisions in the following documents become the provisions of this Standard through reference in this Standard. For dated references, the
subsequent amendments (excluding corrections) or revisions do not apply to this Standard, however, parties who reach an agreement based on this
Standard are encouraged to study if the latest versions of these documents are applicable. For undated references, the latest edition of the referenced document applies.
GB/T 2828.1 Sampling procedures for inspection by attribute – Part 1.
Sampling schemes indexed by acceptance quality limit (AQL) for
lot-by-lot inspection (GB/T 2828.1-2003, ISO 2859-1. 1999, IDT)
YY 0466 Medical devices - Symbols to be used with medical device labels labeling and information to be supplied
ISO 37 Rubber, vulcanized or thermoplastic - Determination of tensile
4 Materials
The glove shall be made from compounding natural rubber latex, For ease of wearing, the surface can be treated with lubricant, powder or polymer covering that meet the requirements of ISO 10993. Any pigment used shall be nontoxic. The material used in surface treatment must be easy to move and bioabsorbable. The gloves provided to users shall meet the requirements of the relevant parts of ISO 10993. Note 1. Other suitable polymeric materials may be included in future versions of this Standard. Note 2. It is generally considered that. After a certain period of time, if some people are sensitive (allergic reaction) to some kinds of special rubber compounding agents, it is required to use the gloves with another recipe.
Note 3. The limits of soluble protein, allergenic protein, residual chemicals, endotoxins and residual powder in gloves may be specified in future versions of this Standard. And it shall comply with the relevant test method standard.
5 Sampling and selection of test pieces
5.1 Sampling
As acceptable use, the glove shall be conducted sampling and inspection according to the requirements of GB/T 2828.1. The inspection level and
acceptance quality limit (AQL) value shall comply with the requirements of Table 1.
When the size of batch amount can not be determined, it shall be assumed that the batch amount is 35 001~150 000.
c) "Pitted surface" or "Smooth surface", "Powdered" or "Powder-free", or other words that have such effects on finished gloves;
d) Dimension;
e) The batch number by manufacturer identification;
f) Words of "Single-use";
j) For Category 1 gloves, indicate that the products is "Made from natural rubber latex that may cause allergic reactions" or similar words.
8.3 Multi-unit packaging
The multi-unit packaging is equivalent to a box of products of a unit packaging of same-size gloves of that the quantity is pre-determined. The purpose is to make it more convenient for transportation and storage. The multi-unit
packaging shall be marked according to 8.2.1 or 8.1.2. And it shall indicate the number of gloves and additional storage instructions.
Appendix A
(Normative)
Impermeability test
A.1 Devices
A.1.1 Cylinder
The minimum diameter is 60mm. And it has sufficient length to fix the glove on it and accommodate 1000mL of water, as shown in Figure A.1.
Note. The cylinder is better to be transparent.
A.1.2 Water filling device
It can make the glove keeping vertical when filling water, as shown in Figure A.2.
A.1.3 Cylindrical measuring cup
The volume is at least 1000mL or other devices that can transfer 1000mL of water at a time.
A.2 Steps
USE suitable device, such as O-ring, to bind the glove on the cylinder. So that the glove would not exceed 40mm from the cylinder.
IMPORT 1000mL ± 50mL of water, of which the temperature does not exceed 36 ºC, into the device. WIPE away any water splashed on the glove. If the water can not rise to 40mm away from the sleeve edge, lift the glove to ensure the entire glove (including the part that is 40mm away from the sleeve edge) to be tested. NOTICE any significant leakage immediately. If there is no
immediate leakage, then observe for 2min~4min. Ignore the leakage within 40mm from the sleeve edge. For ease of observation, it can use water-soluble

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