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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Recognition List Number: 018 Publication Date: 09/12/2007 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 6-187: ASTM F1671-07, Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System. (General Plastic Surgery/General Hospital)

Date of Standard: 2007. 
Address of Standards 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 & Drapes
Processes Affected:
510(k)
Type of Standard:
 Vertical, National
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
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§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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