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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 041 Date of Entry 04/04/2016 
FR Recognition Number 6-355
Standard
ASTM  D3772-15(2021)
Standard Specification for Industrial Rubber Finger Cots
Scope/Abstract
1.1 This specification covers the requirements for finger cots used in industrial applications which are made from natural rubber latex or a synthetic nitrile polymer. The purpose of this specification is to obtain consistent performance among products produced in various locations or at various times in the same location.
1.2 This specification does not cover the safe and proper use of finger cots or products of special construction for special 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 Finger Cot Class 1 LZB
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff - Medical Glove Guidance Manual, Issued January 22, 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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