Recognition List Number: 028 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 Organization: |
| ASTM International (ASTM) |
| 100 Barr Harbor Drive |
| West Conshohocken, PA 19428-2959 |
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| CDRH Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF DEVICE EVALUATION (ODE) | | |
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| (2) | OFFICE OF COMPLIANCE (OC) | | DIVISION OF ENFORCEMENT A (DOEA) |
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| Devices Affected: |
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| Processes Affected: |
| 510(K), IDE, PMA, PDP, HDE, Quality System Regulation |
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| Type of Standard: |
| National, Horizontal |
| Extent of Recognition: |
| Complete standard and any annexes. |
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| 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 |
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| 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 |
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| 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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