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ASTM International (ASTM)
Title

"Standard Specification for Polychloroprene Examination Gloves for Medical Application"

Description

This specification provides certain requirements for polychloroprene rubber gloves used in conducting medical examinations and diagnostic and therapeutic procedures.

Standard Type(s)
Specification

An explicit set of requirements to be satisfied by a material, product, system, or service: Examples of specifications include, but are not limited to, requirements for; physical, mechanical, or chemical properties, and safety, quality, or performance criteria. A specification identifies the test methods for determining whether each of the requirements is satisfied.

Personal Protective Equipment
Hand and Arm Protection

All equipment and/or accessories (whether or not detachable) designed and manufactured specifically to protect the arm and/or the hand this includes all garments protecting the hand or part of the hand, including gloves, fingerless gloves, mittens, garments protecting the fingers only or the palm only, etc. Potential hazards include skin absorption of harmful substances, chemical or thermal burns, electrical dangers, bruises, abrasions, cuts, punctures, fractures and amputations.

  • Medical gloves
Hazards
Biological
  • Biological
SOC Codes
29-0000 Healthcare Practitioners and Technical Occupations
  • 29-1000 Health Diagnosing and Treating Practitioners
    • 29-1063 Internal Medicine Physicians
Standard References
Referenced Standard

ASTM D5151 - 19(2023) - Standard Test method for detection of holes in medical gloves

ASTM D6124 - 06(2022) - Standard Test Method for Residual Powder on Medical Gloves

ASTM D6319 - 19(2023) - Standard Specification for Nitrile Examination Gloves for Medical Application

ASTM D6355 - 07 (Reapproved 2022) - Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves

Conformity Assessment Notes

This specification covers certain requirements for polychloroprene rubber gloves intended for use in medical examinations and diagnostic and therapeutic procedures. Gloves shall be manufactured from any polychloroprene rubber compound, with the inside and outside surfaces of the examination gloves free of talc and with dimensions and physical properties that shall conform to the requirements specified. Tests for sterility, freedom from holes, physical dimensions, tensile strength and ultimate elongation (both before and after accelerated aging of gloves), powder-free residue, and powder amount shall be performed to assess the conformance of the gloves with the requirements specified.

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.  Please see the full standard for complete details.

Comments

Includes performance criteria.

Additional References:

ASTM Standards

  • 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
  • D6319 Specification for Nitrile Examination Gloves for Medical Application
  • D6355 Test Method for Human Repeat Insult Patch Testing of Medical Gloves

ISO Standard

  • ISO 2859 Sampling Procedures and Tables for Inspection by Attributes
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