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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 018 FR Publication Date: 09/12/2007 

Part B: Supplementary Information

Recognition Number 6-199: ASTM F2101-07, standard test method for evaluating the bacterial filtration efficiency (bfe) of medical face mask materials, using a biological aerosol of staphylococcus aureus. (General Plastic Surgery/General Hospital)

Date of Standard: 2007. 
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 Face Masks, Surgical And Surgical Mask Respirators
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 Mask, Surgical Class 2 FXX
§878.4040 Respirator,Surgical Class 2 MSH
Relevant Guidance:
Surgical Masks - Premarket Notification [510(k)] Submissions; Guidance for Industry and FDA, Issued March 5, 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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