| ASTM F2100-11 (Reapproved 2018) Standard Specification for Performance of Materials Used in Medical Face Masks |
| Recognition Number | General Plastic Surgery/General Hospital |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 6-254 |
| Extent | Complete standard |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | General Plastic Surgery/General Hospital |
| FDA Tech | Ramesh K. Panguluri FDA/OMPT/CDRH/ODE/DAGID/INCB/ 301-796-6303 ramesh.panguluri@fda.hhs.gov |
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1.1 This specification covers testing and requirements for materials used in the construction of medical face masks that are used in providing healthcare services such as surgery and patient care.
1.2 This specification provides for the classification of medical face mask material performance. Medical face mask material performance is based on testing for bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency, resistance to penetration by synthetic blood, and flammability.
1.3 This specification does not address all aspects of medical face mask design and performance. This specification does not specifically evaluate the effectiveness of medical face mask designs as related to the barrier and breathability properties. This specification does not also apply to respiratory protection, which may be necessary for some healthcare services.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
| Regulation Number | Device Name | Device Class | Product Code |
| §878.4040 | Mask, Surgical | Class 2 | FXX |
| §878.4040 | Respirator, Surgical | Class 2 | MSH |
| 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 |