GB/T 24786-2025Single-use medical poly (vinyl chloride) examination gloves (English PDF)

1 Scope

This document specifies requirements for non-sterile or sterile disposable polyvinyl chloride (PVC) examination gloves (hereinafter referred to as "gloves") used to prevent cross-infection between patients and users during medical examinations and diagnoses, or for gloves used to prevent cross-infection when treating patients. It also includes gloves used for handling contaminated medical materials.

This document specifies the performance and safety requirements for gloves, but the safe, proper use and sterilization of gloves, as well as subsequent handling, packaging and storage, are not covered in this document.

This document applies to gloves used for medical examinations, diagnosis, or treatment of patients, as well as for handling contaminated medical materials.

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.

GB/T 528, Rubber, vulcanized or thermoplastic -- Determination of tensile stress- strain properties (GB/T 528-2009, ISO 37.2005, IDT)

GB/T 2828.1, Sampling procedures for inspection by attributes -- Part 1.Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection (GB/T2828.1-2012, ISO 2859-1.1999, IDT)

GB/T 2941, Rubber -- General procedures for preparing and conditioning test pieces for physical test methods (GB/T 2941-2025, ISO 23529.2016, IDT)

GB/T 3512, Rubber, vulcanized or thermoplastic -- Accelerated ageing and heat resistance tests -- Air-oven method (GB/T 3512-2014, ISO 188.2011, IDT)

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

NOTE. The degree of conformity between the parts of GB/T 16886 (all parts) and

ISO 10993 (all parts) is given in Annex A.

YY/T 0466.1, Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1.General requirements (YY/T 0466.1-2023, ISO

15223-1.2021, MOD)

YY/T 0466.2, Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2.Symbol development, selection and validation (YY/T0466.2-2015, ISO 15223-2.2010, IDT)

3 Terms and definitions

This document does not contain any terms or definitions that need to be defined.

4 Classification

Finished gloves are classified into the following types.

a) Partially textured or fully textured gloves;

b) Smooth gloves;

c) Powdered gloves;

d) Powder-free gloves.

NOTE 1.Powdered gloves are made by adding powder during the manufacturing process for ease of wear. Powder-free gloves are made without the addition of powder material during the manufacturing process.

NOTE 2.The cuffs of the gloves may be straight or rolled up.

5 Materials

The gloves shall be made of plasticized polyvinyl chloride. For ease of wearing, surface treatment agents, lubricants, powders, or polymer coatings may be used.

Any pigments, surface treatment agents, lubricants, or powders used must be non-toxic and disclosed as required. Migratable substances used for surface treatment must be bioabsorbable.

The materials used shall ensure that the gloves meet the requirements of the relevant parts of GB/T 16886.The manufacturer shall provide the purchaser with data demonstrating compliance with these requirements as required.

NOTE. Based on existing relevant national or industry testing method standards, this document may be revised in the future to specify limits for extractable plasticizers, residual compounds, and residual powders in gloves.

6 Sampling and selection of test pieces

7 Requirements

8 Packaging

If the gloves are sterile, they shall be packaged individually or as a pair.

9 Marks