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This specification covers certain requirements for packaged sterile rubber surgical gloves of the natural rubber latex type (Type 1) and of the synthetic rubber latex type (Type 2). The gloves shall be manufactured from any rubber polymer 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 rubber surgical gloves. The safe and proper use of rubber surgical gloves is beyond the scope of this specification.
1.1 This specification covers certain requirements for packaged sterile rubber surgical gloves used in conducting surgical procedures.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 The following safety hazards caveat pertains only to the test method portion, Section 8, of this specification: This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
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
ICS Number Code 11.140 (Hospital equipment)
UNSPSC Code 42132203(Medical exam or non surgical procedure gloves)