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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Recognition 09/17/2018 
FR Recognition Number 6-254
Standard
ASTM F2100-11 (Reapproved 2018)
Standard Specification for Performance of Materials Used in Medical Face Masks
Scope/Abstract
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.

Extent of Recognition
Complete standard
Transition Period
FDA recognition of ASTM F2100-11 (Reapproved 2018) [Rec# 6-254] will be superseded by recognition of ASTM F2100-19 [Rec# 6-425]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-254] until December 27, 2020. After this transition period, declarations of conformity to [Rec# 6-254] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§878.4040 Mask, Surgical Class 2 FXX
§878.4040 Respirator, Surgical Class 2 MSH
Relevant FDA Guidance and/or Supportive Publications
Surgical Masks - Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff, Issued March 2004.
FDA Technical Contact
 Ramesh K. Panguluri
  FDA/OMPT/CDRH/ODE/DAGID/INCB/
  301-796-6303
  ramesh.panguluri@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
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