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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 028 FR Publication Date: 03/16/2012 

Part B: Supplementary Information

Recognition Number 6-254: ASTM F2100-11, standard specification for performance of materials used in medical face masks. (General Plastic Surgery/General Hospital)

Date of Standard: 2011. 
Address of Standards Development Organization:
 ASTM International (ASTM)
  100 Barr Harbor Drive
  West Conshohocken, PA 19428-2959
 
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
(2)OFFICE OF COMPLIANCE (OC)
DIVISION OF ENFORCEMENT A (DOEA)
Devices Affected:
Surgical Masks
Processes Affected:
510(K), IDE, PMA, PDP, HDE, Quality System Regulation
Type of Standard:
 National, Horizontal
Extent of Recognition:
Complete standard and any annexes.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§878.4040 Mask, Surgical Class 2 FXX
§878.4040 Respirator,Surgical Class 2 MSH
Relevant Guidance:
Guidance for Industry and FDA Staff Surgical Masks - Premarket Notification [510(k)] Submissions. Document issued on: March 5, 2004 and a correction posted on July 14, 2004
FDA Technical Contact:
 Ramesh K. Panguluri, Ph.D
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2506
  Silver Spring MD 20993
  301/796-6303
  email: ramesh.panguluri@fda.hhs.gov
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