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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 049 Date of Entry 06/07/2018 
FR Recognition Number 6-401
Standard
ASTM  D7160-16
Standard Practice for Determination of Expiration Dating for Medical Gloves
Scope/Abstract
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 label claims and 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.
Extent of Recognition
Complete standard
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§878.4460 Surgeon'S Gloves Class 1 KGO
§880.6250 Vinyl Patient Examination Glove Class 1 LYZ
§880.6250 Polymer Patient Examination Glove Class 1 LZA
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA - Medical Glove Guidance Manual. Issued January 2008.

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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