| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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065
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Date of Entry 12/22/2025
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FR Recognition Number
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6-517
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| Standard | |
ASTM F3502-25
Standard Specification for Barrier Face Coverings |
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Scope/Abstract1.1 This specification is intended to help ensure barrier face coverings meeting the stated requirements provide (1) a means of source control for individual wearers by reducing expelled aerosols from the wearer's nose and mouth into the air; and (2) a degree of particulate filtration that potentially reduces the amount of aerosols inhaled by the wearer.
Note 1: The source control/protection provided by barrier face coverings depends on several factors not considered in this specification, such as material degradation from wearer challenges including perspiration, talking, sneezing, and the length of time the barrier face covering is worn. Further research is needed to expand the evidence base for the protective effect of face coverings and, in particular, to identify the combinations of materials that maximize both their blocking and filtering effectiveness, as well as fit, comfort, durability, and consumer appeal. (https://www.cdc.gov/coronavirus/2019-ncov/more/masking-science-sars-cov2.html.)
Note 2: There are currently no established methods for measuring outward leakage from a barrier face covering, medical mask, or respirator. Nothing in this specification addresses or implies a quantitative assessment of outward leakage and no claims can be made about the degree to which a barrier face covering reduces expired human-generated aerosols.
1.2 This specification establishes minimum design, performance (testing), labeling, user instruction, reporting and classification, and conformity assessment requirements for barrier face coverings.
... |
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| Extent of Recognition
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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. |
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Transition Period
| FDA recognition of ASTM F3502-22a [Rec# 6-484] will be superseded by recognition of ASTM F3502-25 [Rec# 6-517]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-484] until December 19, 2027. After this transition period, declarations of conformity to [Rec# 6-484] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| N/A |
Barrier Face Covering Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy |
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QOZ
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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.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contact
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| Standards Development Organization
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FDA Specialty Task Group (STG)
| General Plastic Surgery/General Hospital |
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| *These are provided as examples and others may be applicable. |
