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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 026 FR Publication Date: 03/18/2011 

Part B: Supplementary Information

Recognition Number 6-169: ASTM D3772-01 (Reapproved 2010), standard specification for natural rubber finger cots. (General Plastic Surgery/General Hospital)

Date of Standard: 2001. 
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:
Rubber Examination Gloves
Processes Affected:
510(k), HDE, PMA, PreIDE, IDE, HDE
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete Standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§880.6250 Finger Cot Class 1 LZB
Relevant Guidance:
Guidance for 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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