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Significance and Use
This practice provides a study design for determining shelf life of medical gloves using product in its final packaging configuration that has been stored under typical warehouse conditions.
1.1 This practice covers all surgeon's and examination gloves, made from either synthetic or natural rubber latex, marketed at the time this practice is published, for which there is no previous real time aging data available, and for which there are at least 12 months of storage as finished goods under typical warehouse conditions. This practice describes how to develop real time aging data for gloves that are part of finished goods inventory (including gloves that may no longer be manufactured) in order to verify the estimated expiration date (see Note 1). Manufacturers may use this data as a starting point for real time aging studies as described in Practice D7160.
Note 1—Accelerated aging for three-year shelf life is described in Practice D7160.
1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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
D3078 Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
D3577 Specification for Rubber Surgical Gloves
D3578 Specification for Rubber Examination Gloves
D5151 Test Method for Detection of Holes in Medical Gloves
D5250 Specification for Poly(vinyl chloride) Gloves for Medical Application
D6319 Specification for Nitrile Examination Gloves for Medical Application
D7160 Practice for Determination of Expiration Dating for Medical Gloves
F88 Test Method for Seal Strength of Flexible Barrier Materials
F1929 Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
ICS Number Code 11.140 (Hospital equipment)
UNSPSC Code 42132203(Medical exam or non surgical procedure gloves)