ASTM D6319 - 19
Standard Specification for Nitrile Examination Gloves for Medical Application
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Abstract
This specification contains test procedures for evaluating the performance and safety of nitrile rubber gloves for use in conducting medical examinations and diagnostic and therapeutic procedures. The products covered by this specification include nitrile rubber gloves that fit either hand, paired gloves, and gloves by size and packaged sterile or nonsterile or bulk nonsterile. An approved lubricant for absorbable dusting powder may be applied to the gloves. Other lubricants may also be used, provided, that their safety and efficacy have been previously established. Both the inside and outside surface of the glove should be free of talc. All products should meet the required degree of sterility, freedom from holes, physical requirements before and after ageing, amount of powder on the glove, tensile strength and ultimate elongation.
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.
1. Scope
1.1 This specification covers certain requirements for nitrile rubber gloves used in conducting medical examinations and diagnostic and therapeutic procedures.
1.2 This specification covers nitrile rubber examination gloves that fit either hand, paired gloves, and gloves by size. It also provides for packaged sterile or nonsterile or bulk nonsterile nitrile rubber examination gloves.
1.3 This specification is similar to that of Specification D3578 for rubber examination gloves.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 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.
ASTM Standards
D412 Test Methods for Vulcanized Rubber and Thermoplastic ElastomersTension
D573 Test Method for RubberDeterioration in an Air Oven
D3578 Specification for Rubber Examination Gloves
D3767 Practice for Rubber--Measurement of Dimensions
D5151 Test Method for Detection of Holes in Medical Gloves
D6124 Test Method for Residual Powder on Medical Gloves
Other Documents
U.S. Pharmacopeia U. S. Pharmacopeia, latest editiICS Code
ICS Number Code 11.140 (Hospital equipment)
UNSPSC Code
UNSPSC Code 42132203(Medical exam or non surgical procedure gloves)
Referencing This Standard
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DOI: 10.1520/D6319-19
Citation Format
ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application, ASTM International, West Conshohocken, PA, 2019, www.astm.org
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