Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 065 Date of Entry 12/22/2025 
FR Recognition Number 6-519
Standard
ASTM  F2101-25
Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
Scope/Abstract
1.1 This test method is used to measure the bacterial filtration efficiency (BFE) of medical face mask materials, employing a ratio of the upstream bacterial challenge to downstream residual concentration to determine filtration efficiency of medical face mask materials.

1.2 This test method is a quantitative method that allows filtration efficiency for medical face mask materials to be determined. The maximum filtration efficiency that can be determined by this method is 99.9%.
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.

Note: Appendix X1 may become inconsistent with the normative portion of this standard when applying it to your device. We encourage you to contact revision division regarding Appendix X1.
Transition Period
FDA recognition of ASTM F2101-23 [Rec# 6-493] will be superseded by recognition of ASTM F2101-25 [Rec# 6-519]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-493] until December 19, 2027. After this transition period, declarations of conformity to [Rec# 6-493] 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*
1. The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], Guidance for Industry and Food and Drug Administration Staff, July 2014

2. Surgical Masks - Premarket Notification [510(k)] Submissions; Guidance for Industry and FDA, issued March 2004.

3. Content of a 510(k). https://www.fda.gov/medical-devices/premarket-notification-510k/content-510k, updated April 2019.

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.
-
-