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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 031 FR Publication Date: 08/05/2013 

Part B: Supplementary Information

Recognition Number 6-147: ASTM D6978-05 (Reapproved 2013), standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs. (General Plastic Surgery/General Hospital)

Date of Standard: 2005. 
Address of Standards Development Organization:
 ASTM International (ASTM)
  100 Barr Harbor Drive
  West Conshohocken, PA 19428-2959
 
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Medical gloves (examination and surgeon's gloves)
Processes Affected:
510(k)
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
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 Polymer Patient Examination Glove Class 1 LZA
§880.6250 Vinyl Patient Examination Glove Class 1 LYZ
Relevant Guidance:
Guidance of Industry and FDA Staff - Medical Glove Guidance Manual, Issued January 22, 2008
FDA Technical Contact:
 Terrell Cunningham
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2502
  Silver Spring MD 20993
  301/796-6299
  email: terrell.cunningham@fda.hhs.gov
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