GB/T 24786-2025 PDF English
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GB/T 24786: Historical versions
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| GB/T 24786-2025 | 275 | Add to Cart | Auto, 9 seconds. | Single-use medical poly (vinyl chloride) examination gloves | Valid |
| GB 24786-2009 | 145 | Add to Cart | Auto, 9 seconds. | Single-use medical poly (vinyl chloride) examination gloves | Valid |
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GB/T 24786-2025: Single-use medical poly (vinyl chloride) examination gloves
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GBT24786-2025GB NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.140; 83.140.99 CCS G 45 Replacing GB 24786-2009 Single-use medical poly (vinyl chloride) examination gloves [ISO 11193-2.2006, Single-use examination gloves -- Part 2.Specification for gloves made from ploy (vinyl chloride), MOD] Issued on: AUGUST 29, 2025 Implemented on: SEPTEMBER 01, 2026 Issued by. State Administration for Market Regulation; Standardization Administration of the People's Republic of China.
Table of Contents
Foreword... 3 1 Scope... 5 2 Normative references... 5 3 Terms and definitions... 6 4 Classification... 6 5 Materials... 6 6 Sampling and selection of test pieces... 7 7 Requirements... 7 8 Packaging... 10 9 Marks... 10 Annex A (informative) Degree of conformity between GB/T 16886 (all parts) and ISO 10993 (all parts)... 12 Annex B (normative) Test method for impermeability... 14 Single-use medical poly (vinyl chloride) examination gloves WARNING -- Users of this document shall be familiar with general laboratory procedures. This document does not address all safety issues; users are responsible for taking appropriate health precautions and complying with relevant national regulations.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
6.1 Sampling For testing purposes, gloves shall be sampled and inspected in accordance with the requirements of GB/T 2828.1.The inspection level and acceptable quality limit (AQL) values shall conform to the provisions of Table 1. When the batch size cannot be determined, it shall be assumed to be between 35001~150000 pieces. 6.2 Selection of test pieces Test pieces shall be cut from the palm or back of the glove.7 Requirements
7.1 Dimensions When measured at the location shown in Figure 1, the length and palm width of the gloves shall conform to the specifications in Table 2.Inspection levels and acceptable quality limits (AQLs) are shown in Table 1. The length shall be the shortest distance from the tip of the middle finger to the edge of the cuff. Length measurement can be performed by suspending the glove on a suitable round bar with a top radius of 5 mm. When measuring the width, the glove shall be laid flat. Measure the distance from the inside of the index finger to the outside of the ring finger. The width shall be measured at the midpoint between the base of the index finger and the base of the thumb. The double-layer thickness of the gloves is measured according to GB/T 2941.A foot 7.3.3 Tensile force and elongation at break after accelerated aging Accelerated aging tests shall be conducted according to the method specified in GB/T3512.Samples may be cut from gloves after accelerated aging at (70±2)℃ × (168±2) h. Alternatively, specimens may be cut from gloves and then aged under the above conditions. Tensile tests shall be conducted according to 7.3.2. 7.4 Sterilization If the gloves are sterilized, the type of sterilization treatment shall be labeled as required.8 Packaging
If the gloves are sterile, they shall be packaged individually or as a pair.9 Marks
9.1 General The marks shall conform to the requirements specified in this document. Appropriate symbols in YY/T 0466.1 and YY/T 0466.2 may be used on the label. The language used for the marks shall be agreed upon by the relevant parties. 9.2 Unit packaging 9.2.1 Sterilization packaging A single glove or a pair of gloves packaged in one bag constitutes unit packaging. The following information shall be clearly labeled. a) Name or trademark of the manufacturer or supplier; b) Materials used; c) Terms describing the glove's surface treatment, such as "textured," "smooth," "powdered," "powder-free," or other terms; d) Size code/specification; e) For gloves treated with any surface material, include a warning stating that surface powder must be aseptically removed before wearing; f) Manufacturer-identified batch number; g) "Date of manufacture" or similar wording, including the year (four digits) and the month of manufacture; ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
