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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
5.1 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.
1.1 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.
1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
Other DocumentsISO 2859 U. S. Pharmacopeia U.S. Pharmacopeia, latest editi
D412 Test Methods for Vulcanized Rubber and Thermoplastic ElastomersTension
D573 Test Method for RubberDeterioration 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 Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method
D6124 Test Method for Residual Powder on Medical Gloves
D6499 Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products
ICS Number Code 11.140 (Hospital equipment)
UNSPSC Code 42132203(Medical exam or non surgical procedure gloves)
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ASTM D3578-19, Standard Specification for Rubber Examination Gloves, ASTM International, West Conshohocken, PA, 2019, www.astm.orgBack to Top