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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 056 Date of Entry 03/01/2021 
FR Recognition Number 6-460
Standard
ASTM F3502-21
Standard Specification for Barrier Face Coverings
Scope/Abstract
1.1 This specification is primarily intended to help ensure barrier face coverings meeting the stated requirements provide (1) a means of source control for individual wearers by reducing the number of expelled droplets* and aerosols from the wearer's nose and mouth into the air; and (2) to potentially offer a degree of particulate filtration to reduce the amount of inhaled particulate matter by the wearer.
1.2 This specification establishes minimum design, performance (testing), labeling, user instruction, reporting and classification, and conformity assessment requirements for barrier face coverings.
1.2.1 Design criteria include setting minimum areas of face coverage over the wearer's nose and mouth, prohibiting open vents or valves, requiring a means for retaining the barrier face covering on the wearer's head, and providing a representation of product sizing. Manufacturers are further required to perform a design analysis for assessing leakage of exhaled air from the barrier face covering. Manufacturers are permitted to conduct quantitative testing as specified in this standard to supplement the design analysis.
1.2.2 Performance and testing criteria define minimum barrier face covering filtration efficiency and airflow resistance performance properties. Sub-micron particulate filtration efficiency represents the ability to capture and reduce respirable droplets* and aerosols that potentially contain viruses and bacteria. Airflow resistance represents the wearer's ease of breathing or breathability while wearing the barrier face covering. The impact of repeated cleaning or laundering on continued performance is applied for measuring performance properties for those barrier face coverings that are intended to be reusable. Manufacturers are permitted to also provide test results for bacterial filtration efficiency (BFE) as supplemental information to the mandatory performance measurement of sub-micron particulate filtration efficiency.

* See Extent of Recognition section below for further information.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
The use of the word "droplets" in Subsections 1.1, 1.2.2, and 3.1.12.
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.

This standard is recognized in part because:
The use of the word "droplets" in Subsections 1.1, 1.2.2, and 3.1.12 is not consistent with the rest of this standard itself in that there are no corresponding Sections in the standard defining an appropriate test method by which the reduction in the number of expelled droplets from the wearer is quantitatively measured or the liquid barrier performance is evaluated. Droplets are considered liquid in nature and may not be adequately contained without some degree of liquid barrier evaluation and requirement.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
Unclassified Barrier Face Covering Per Enforcement Policy For Face Masks And Respirators During The Covid-19 Public Health Emergency Class N QOZ
Relevant FDA Guidance and/or Supportive Publications*
1. 42 CFR Part 84 Approval of Respiratory Protective Devices.
2. Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised), Guidance for Industry and Food and Drug Administration Staff, Issued September 2021.
FDA Technical Contacts
 Kira Moore
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  301-796-9568
  Kira.Moore@fda.hhs.gov
 Jessica Mavadia-Shukla
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVA
  301-348-1596
  Jessica.Mavadia-Shukla@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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