ASTM D3578 - 05(2010)

    Standard Specification for Rubber Examination Gloves

    Active Standard ASTM D3578 | Developed by Subcommittee: D11.40

    Book of Standards Volume: 09.02


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    Abstract

    This specification covers certain requirements for natural rubber gloves intended for use in medical examinations and diagnostic and therapeutic procedures as well as in handling contaminated medical material. Material under this specification consists of Type I and Type II gloves, which shall be manufactured from any natural rubber compound, with the inside and outside surfaces of the gloves free of talc and with dimensions and physical properties that shall conform to the requirements specified. Tests for sterility, freedom from holes, physical dimensions, tensile strength, ultimate elongation, stress at elongation, powder-free residue, powder amount, protein content, and antigenic protein content shall be performed to assess the conformance of the rubber gloves with the requirements specified.

    This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.

    Significance and Use

    The specification is intended as a reference to the performance and safety of natural rubber examination gloves. The safe and proper use of natural rubber examination gloves is beyond the scope of this specification.

    1. Scope

    1.1 This specification covers certain requirements for natural rubber gloves used in conducting medical examinations and diagnostic and therapeutic procedures. It also covers natural rubber gloves used in handling contaminated medical material.

    1.2 This specification provides for natural rubber gloves that fit either hand, paired gloves, and gloves by size. It also provides for packaged sterile natural rubber gloves and packaged or bulk nonsterile natural rubber gloves.


    2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    ASTM Standards

    D412 Test Methods for Vulcanized Rubber and Thermoplastic Elastomers--Tension

    D573 Test Method for Rubber--Deterioration in an Air Oven

    D3767 Practice for Rubber--Measurement of Dimensions

    D5151 Test Method for Detection of Holes in Medical Gloves

    D5712 Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method

    D6124 Test Method for Residual Powder on Medical Gloves

    D6499 Test Method for The Immunological Measurement of Antigenic Protein in Natural Rubber and its Products

    Other Documents

    U.S.PharmacopeiaU.S.


    ICS Code

    ICS Number Code 11.140 (Hospital equipment)

    UNSPSC Code

    UNSPSC Code 42132203(Medical exam or non surgical procedure gloves)


    DOI: 10.1520/D3578-05R10

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