ASTM D5250 - 19
Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
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Abstract
This specification contains procedures for evaluating the performance and safety of poly(vinyl chloride) gloves for use in conducting medical examinations, diagnostic and therapeutic procedures, and handling contaminated medical materials. The products covered by this specification include poly(vinyl chloride) gloves that fit either hand, paired gloves, and gloves by size and packaged sterile or nonsterile or bulk nonsterile. This specification does not include two-dimensional heat sealed poly(vinyl chloride) gloves. 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.
Significance and Use
4.1 The specification is intended as a referee procedure for evaluating the performance and safety of poly(vinyl chloride) examination gloves. The safe and proper use of poly(vinyl chloride) examination gloves is beyond the scope of this standard.
1. Scope
1.1 This specification covers certain requirements for poly(vinyl chloride) gloves used in conducting medical examinations and diagnostic and therapeutic procedures. It also covers poly(vinyl chloride) gloves used in handling contaminated medical material.
1.2 This specification provides for poly(vinyl chloride) gloves that fit either hand, paired gloves, and gloves by size. It also provides for packaged sterile or nonsterile or bulk nonsterile poly(vinyl chloride) gloves.
1.3 This specification does not cover two-dimensional heat sealed poly(vinyl chloride) gloves.
1.4 This specification is similar to that of Specification D3578 for rubber examination gloves.
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
ICS Code
ICS Number Code 11.140 (Hospital equipment)
UNSPSC Code
UNSPSC Code 42132200(Medical gloves and accessories); 13102030(Polyvinyl Chloride PVC)
Referencing This Standard
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DOI: 10.1520/D5250-19
Citation Format
ASTM D5250-19, Standard Specification for Poly(vinyl chloride) Gloves for Medical Application, ASTM International, West Conshohocken, PA, 2019, www.astm.org
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