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.
Область применения1.1 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.