ASTM D7103-06e1 - 15.2.2006
 
Significance and Use

The standards under the jurisdiction of Committee D11.40 and other technical committees can be used individually or as part of an integrated protocol in the assessment and selection of medical gloves.

The intended use of the standards is as a means by which information can be requested, generated, and reported in a consistent, comparable manner.

The suggested assessments and test methods are recommended guidelines.

Test methods offer procedures for assessing medical gloves at standardized conditions to allow comparison.

The information on medical glove performance must be combined with professional judgment, and a clear understanding of the application, in order for the medical glove to provide the best performance.

Medical gloves intended for use during emergency medical operations may be evaluated and their performance certified to NFPA 1999, Standard on Protective Clothing for Emergency Medical Operations. This certification program is voluntary.

 
1. Scope

1.1 This guide is intended to assist in the identification and application of the most appropriate ASTM and associated standards for the assessment, development of specifications, and selection of medical gloves with the ultimate goal of maintaining the safety and health of healthcare workers who may come into contact with biological and chemical hazards.

1.2 No guidance document or assessment protocol can ensure the selection of medical gloves that guarantees healthcare worker protection. The purpose of testing and assessing medical gloves is to generate the performance data and quality information that will allow the most appropriate assessment and selection of medical gloves. Ultimately, the selection of medical gloves shall be based on the evaluation of available technical data, quality information, and professional assessment of risk.

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

NFPA 1999

Standard on Protective Clothing for Emergency Medical Operations Available from National Fire Protection Association (NFPA), 1 Batterymarch Park, Quincy, MA 02269-9101.

D3578-19(2023)

Standard Specification for Rubber Examination Gloves

Acceptance Program Guidelines

Infection Control Products Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036.

Specification No. 76

Non-Sterile Natural Rubber Latex Gloves for Dentistry

Specification No. 102

Non-Sterile Nitrile Gloves for Dentistry

Specification No. 103

Non-Sterile Poly(vinyl chloride) Gloves for Dentistry

ISO 2859

Sampling Procedures and Tables for Inspection by Attributes

D3767-03(2020)

Standard Practice for Rubber´Measurement of Dimensions

D3577-19(2023)

Standard Specification for Rubber Surgical Gloves

D5151-19(2023)

Standard Test Method for Detection of Holes in Medical Gloves

F1383-20

Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Intermittent Contact

F1671-07

Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System

D5250-19(2023)

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

D5712-15(2025)

Standard Test Method for Analysis of Aqueous Extractable Protein in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method

D6124-06(2022)

Standard Test Method for Residual Powder on Medical Gloves

D6319-19(2023)

Standard Specification for Nitrile Examination Gloves for Medical Application

D6499-24

Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products

D6977-19(2023)

Standard Specification for Polychloroprene Examination Gloves for Medical Application

F739-20

Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact

F1342-05

Standard Test Method for Protective Clothing Material Resistance to Puncture

D573-04(2025)

Standard Test Method for Rubber—Deterioration in an Air Oven

D412-16(2021)

Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension