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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 054 Date of Entry 07/06/2020 
FR Recognition Number 6-442
Standard
ASTM  D6977-19(2023)
Standard Specification for Polychloroprene Examination Gloves for Medical Application
Scope/Abstract
1.1 This specification provides certain requirements for polychloroprene rubber gloves used in conducting medical examinations and diagnostic and therapeutic procedures.
1.2 This specification covers polychloroprene rubber examination gloves that fit either hand, paired gloves, and gloves by . It also provides for packaged sterile or non-sterile or bulk non-sterile polychloroprene rubber examination gloves.
1.3 This specification is similar to that of D3578 Standard Specification for Rubber Examination Gloves, and D6319 Standard Specification for Nitrile Examination Gloves for Medical Applications.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
All text related to Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove.
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

This standard is recognized in part because:
The Food and Drug Administration (FDA) has determined that Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling. Consequently, FDA is banning these devices.

The FDA does not recognize this/these clause(s) in this standard because Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling. See Final Rule below.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.6250 Polymer Patient Examination Glove Class 1 LZA
Relevant FDA Guidance and/or Supportive Publications*
1. Guidance for Industry and FDA Staff - Medical Glove Guidance Manual, Issued January 22, 2008.

2. Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex - Guidance for Industry and Food and Drug Administration Staff, Issued December 2, 2014.

3. Final Rule: https://www.fda.gov/medical-devices/medical-device-safety/medical-device-bans.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Allan Guan
  FDA/CDRH/OPEQ/OHTIV/DHTIVB
  301-796-2851
  Allan.Guan@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
*These are provided as examples and others may be applicable.
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