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Significance and Use
4.1 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.
4.2 The intended use of the standards is as a means by which information can be requested, generated, and reported in a consistent, comparable manner.
4.3 The suggested assessments and test methods are recommended guidelines.
4.4 Test methods offer procedures for assessing medical gloves at standardized conditions to allow comparison.
4.5 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.
4.6 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.
1.1 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.
1.3 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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 ElastomersTension
D573 Test Method for RubberDeterioration in an Air Oven
D3577 Specification for Rubber Surgical Gloves
D3578 Specification for Rubber Examination Gloves
D3767 Practice for Rubber--Measurement of Dimensions
D5151 Test Method for Detection of Holes in Medical Gloves
D5250 Specification for Poly(vinyl chloride) Gloves for Medical Application
D5712 Test Method for Analysis of Aqueous Extractable Protein in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method
D6124 Test Method for Residual Powder on Medical Gloves
D6319 Specification for Nitrile Examination Gloves for Medical Application
D6355 Test Method for Human Repeat Insult Patch Testing of Medical Gloves
D6499 Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products
D6977 Specification for Polychloroprene Examination Gloves for Medical Application
D6978 Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
D7102 Guide for Determination of Endotoxin on Sterile Medical Gloves
D7160 Practice for Determination of Expiration Dating for Medical Gloves
D7161 Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions
D7198 Specification for Disposable Embalming Gloves for Single-Use Applications
D7427 Test Method for Immunological Measurement of Four Principal Allergenic Proteins (Hev b 1, 3, 5 and 6.02) in Hevea Natural Rubber and Its Products Derived from Latex
D7558 Test Method for Colorimetric/Spectrophotometric Procedure to Quantify Extractable Chemical Dialkyldithiocarbamate, Thiuram, and Mercaptobenzothiazole Accelerators in Natural Rubber Latex and Nitrile Gloves
D7907 Test Methods for Determination of Bactericidal Efficacy on the Surface of Medical Examination Gloves
F739 Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact
F1342 Test Method for Protective Clothing Material Resistance to Puncture
F1383 Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Intermittent Contact
F1671 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
F2547 Test Method for Determining the Attenuation Properties in a Primary X-ray Beam of Materials Used to Protect Against Radiation Generated During the Use of X-ray Equipment
American National Standards Institute/American Dental Association (ANSI/ADA) StandardsAcceptance Program Guidelines Specification No. 102 Non-Sterile Nitrile Gloves for Dentistry Specification No. 103 Non-Sterile Poly(vinyl chloride) Gloves for Dentistry
International Standards Organization (ISO) StandardISO 2859
National Fire Protection Association (NFPA) StandardNFPA 1999
ICS Number Code 11.140 (Hospital equipment)
UNSPSC Code 42132203(Medical exam or non surgical procedure gloves)
|Link to Active (This link will always route to the current Active version of the standard.)|
ASTM D7103-19, Standard Guide for Assessment of Medical Gloves, ASTM International, West Conshohocken, PA, 2019, www.astm.orgBack to Top