ASTM D7160-05(2010) - 15.6.2010
 
1. Scope

1.1 This practice covers all surgeon's and examination gloves made from either synthetic or natural rubber latex. The purpose of this practice is to establish methods for testing medical gloves and analyzing the data to determine their shelf life.

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

D573-04(2025)

Standard Test Method for Rubber—Deterioration in an Air Oven

D3078-02(2021)e1

Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission (Includes all amendments and changes 2/15/2021).

D3577-19(2023)

Standard Specification for Rubber Surgical Gloves

D412-16(2021)

Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension

D5151-19(2023)

Standard Test Method for Detection of Holes in Medical Gloves

D5250-19(2023)

Standard Specification for Poly(vinyl chloride) Gloves for Medical Application

D6319-19(2023)

Standard Specification for Nitrile Examination Gloves for Medical Application

D7161-16(2023)

Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions

F88-07

Standard Test Method for Seal Strength of Flexible Barrier Materials

F1929-23

Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration

F1980-21

Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices

D3578-19(2023)

Standard Specification for Rubber Examination Gloves

ISO 2859

Sampling Procedures for Inspection by Attributes

ISO 4074

Natural Latex Rubber CondomsRequirements and Test Methods