GB/T 10213-2025 Single-use medical rubber examination gloves English, Anglais, Englisch, Inglés, えいご
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Contents
Foreword
1 Scope
2 Normative References
3 Terms and Definitions
4 Classification
5 Materials
6 Sampling and Test Piece Selection
7 Requirements
8 Packaging
9 Marking
Single-use medical rubber examination gloves
Warning: Users of this document should be familiar with standard laboratory practices. This document does not address all safety issues, and users are responsible for implementing appropriate health measures and complying with relevant national regulations.
1 Scope
This document specifies requirements for sterile or non-sterile single-use medical examination rubber gloves (hereinafter referred to as "gloves") intended to prevent cross-contamination between patients and users during medical examination and diagnostic procedures, including gloves used for handling contaminated medical materials.
This document applies to gloves with smooth, partially textured, or fully textured surfaces.
It specifies performance and safety requirements for gloves but does not cover their safe and correct use, sterilization processes, subsequent handling, packaging, or storage.
2 Normative References
The following referenced documents contain provisions that are essential to this document. For dated references, only the cited version applies. For undated references, the latest version (including amendments) applies.
ISO 37 Rubber, vulcanized or thermoplastic — Determination of tensile stress-strain properties
Note: GB/T 528-2009 equivalent
ISO 188 Rubber, vulcanized or thermoplastic — Accelerated ageing and heat resistance tests
Note: GB/T 3512-2014 equivalent
ISO 2859-1 Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
Note: GB/T 2828.1-2012 equivalent
ISO 10993 (all parts) Biological evaluation of medical devices
Note: GB/T 16886 (all parts) equivalent
ISO 23529 Rubber — General procedures for preparing and conditioning test pieces for physical test methods
Note: GB/T 2941-2025 equivalent
3 Terms and Definitions
No terms or definitions are specified in this document.
4 Classification
4.1 General
Gloves are classified by category and surface type, as specified in 4.2 and 4.3.
4.2 Category
a) Category 1: Gloves primarily made from natural rubber latex.
b) Category 2: Gloves primarily made from nitrile rubber latex, chloroprene rubber latex, styrene-butadiene rubber solution, styrene-butadiene rubber emulsion, or thermoplastic elastomer solution.
4.3 Surface Type
a) Partially or fully textured gloves;
b) Smooth-surface gloves;
c) Powdered-surface gloves;
Note 1: Powdered-surface gloves are treated with powder during manufacturing for easier donning. The maximum residual powder allowed is 10 mg per glove.
d) Non-powdered-surface gloves.
Note 2: Non-powdered-surface gloves are manufactured without added powder. The maximum residual powder allowed is 2.0 mg per glove.
Note 3: Gloves may have straight or rolled cuffs.
5 Materials
Gloves shall be made from:
compounded natural rubber latex
compounded nitrile rubber latex
compounded styrene-butadiene rubber or thermoplastic elastomer solution, or
compounded styrene-butadiene rubber latex**.
For ease of donning, surface treatments such as lubricants, powders, or polymer coatings may be used, provided they comply with ISO 10993 (all parts).
All pigments, surface treatments, lubricants, or powders used must be non-toxic and disclosed as required.
Migratable substances used in surface treatment shall be biodegradable.
Materials shall ensure compliance with relevant parts of ISO 10993. Manufacturers shall provide data upon request to demonstrate compliance.
Note 1: future parts of ISO 11193 may include additional polymer materials.
Note 2: Some individuals may develop sensitivity (allergic reactions) to certain rubber compounding agents over time, necessitating alternative formulations.
Future versions of this document may specify limits for soluble proteins, allergenic proteins, residual chemicals, endotoxins, and residual powder, along with applicable test methods.
6 Sampling and Test Piece Selection
6.1 Sampling
For arbitration, gloves shall be sampled and inspected per ISO 2859-1, with inspection levels and Acceptance Quality Limits (AQLs) as specified in Table 1.
If batch size cannot be determined, a lot size of 35,001 to 150,000 gloves shall be assumed.
6.2 Test Piece Selection
Test pieces shall be cut from the palm or back of the glove.
7 Requirements
7.1 Dimensions
When measured at the positions shown in Figure 1, the length and palm width of gloves shall comply with Table 2. The inspection levels and Acceptance Quality Limit (AQL) shall be as specified in Table 1.
Length shall be the shortest distance from the tip of the middle finger to the cuff edge.
Length measurement shall be performed with the glove suspended over a suitable round bar with a 5 mm radius.
