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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 053 Date of Entry 12/23/2019 
FR Recognition Number 6-425
Standard
ASTM  F2100-19
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 apply to regulated respiratory protection, which may be necessary for some healthcare services.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Transition Period
FDA recognition of ASTM F2100-19 [Rec# 6-425] will be superseded by recognition of ASTM F2100-23 [Rec# 6-492]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-425] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 6-425] 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
Relevant FDA Guidance and/or Supportive Publications*
Surgical Masks - Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff, Issued March 2004.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Ramesh K. Panguluri
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  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
*These are provided as examples and others may be applicable.
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