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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 022 FR Publication Date: 09/08/2009 

Part B: Supplementary Information

Recognition Number 6-217: ASTM F1670-08, standard test method for resistance of materials used in protective clothing to penetration by synthetic blood. (General Plastic Surgery/General Hospital)

Date of Standard: 2008. 
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:
Gowns and Drapes
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
§878.4040 Gown, Surgical Class 2 FYA
§878.4370 Drape, Surgical Class 2 KKX
Relevant Guidance:
Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, Issued August 1993
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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