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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 031 Date of Entry 08/06/2013 
FR Recognition Number 6-147
Standard
ASTM  D6978-05(2023)
Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
Scope/Abstract
1.1 This practice covers a protocol for the assessment of resistance of medical glove materials to permeation by potentially hazardous cancer chemotherapy drugs under conditions of continuous contact. An assessment is made based on the permeation (breakthrough) of nine chemotherapy drugs through the glove material over a certain period of time.
1.2 It is emphad that the conditions used in this assessment are intended to approximate the worst-case condition for clinical uses. The data should be restricted to use on a relative basis when comparing glove materials.
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 Latex Patient Examination Glove Class 1 LYY
§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 of 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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