This specification includes test procedures to evaluate the performance and safety of nitrile rubber gloves for use in the conduct of medical examinations and diagnostic and therapeutic procedures.
Products covered by this specification include sterile or non-sterile or bulk non-sterile nitrile rubber gloves that fit hand, double gloves and gloves by size.
Gloves can be treated with a lubricant approved for absorbable powder dust. Other lubricants may also be used, provided their safety and effectiveness have been determined beforehand.
Both the inner and outer surfaces of the glove should be free of talc. All products must meet the required degree of sterility, no holes, physical requirements before and after aging, amount of powder on the glove, tensile strength and ultimate elongation.
Values stated in SI units should be accepted as standard. No other units of measurement are included in this standard.
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