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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.
Significance and Use
IRMs are vitally important in product and specification testing, in research and development work, in technical service work, and in quality control operations in the rubber and carbon black industries. They are especially valuable for referee purposes. Many ASTM rubber standards for the evaluation of natural or synthetic rubber require the use of specific IRMs in their test recipes for better laboratory repeatability and reproducibility.
New material lots that have been selected as candidates for IRM approval shall conform to the appropriate specifications given in this standard and meet requirements given in Practice D4678 before the lots may be accepted as IRMs.
The chemical and physical IRM specifications shown will ensure some consistency in IRM properties from one lot to the next. However, the specifications cannot ensure exact inter-lot consistency.
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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
D412 Test Methods for Vulcanized Rubber and Thermoplastic Elastomers--Tension
D573 Test Method for Rubber--Deterioration 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 Number Code 11.140 (Hospital equipment)
UNSPSC Code 42132203(Medical exam or non surgical procedure gloves)