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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 049 Date of Recognition 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
§880.6250 Polymer Patient Examination Glove Class 1 LZA
§880.6250 Vinyl Patient Examination Glove Class 1 LYZ
§878.4460 Surgeon'S Gloves Class 1 KGO
Relevant FDA Guidance and/or Supportive Publications
Guidance for Industry and FDA - Medical Glove Guidance Manual. Issued January 2008.
FDA Technical Contact
 Elizabeth Claverie
  FDA/OMPT/CDRH/ODE/DAGID/INCB/
  301-796-6298
  elizabeth.claverie@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
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