ASTM D6319

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 D 3578 for rubber examination gloves.

2. Referenced Documents

ASTM Standards
D3578 Specification for Rubber Examination Gloves
D3767 Practice for Rubber--Measurement of Dimensions
D412 Test Methods for Vulcanized Rubber and Thermoplastic Elastomers--Tension
D5151 Test Method for Detection of Holes in Medical Gloves
D573 Test Method for Rubber--Deterioration in an Air Oven
D6124 Test Method for Residual Powder on Medical Gloves
ISO Standard
ISO 2859 Sampling Procedures and Tables for Inspection by Attributes
Other Documents
U.S. Pharmacopeia

Index Terms

examination gloves; nitrile; rubber; Medical examination gloves--specifications; Nitrile rubber; Rubber medical/surgical applications--specifications; ICS Number Code 11.140 (Hospital equipment)

Citing ASTM Standards

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