| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
060
|
Date of Entry 05/29/2023
|
|
FR Recognition Number
|
6-492
|
| Standard | |
ASTM F2100-23
Standard Specification for Performance of Materials Used in Medical Face Masks |
|
Scope/Abstract1.1 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.
1.1.1 This specification addresses medical masks with ties (surgical masks) and ear loops (procedure masks or isolation masks).
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 their overall barrier and breathability properties.
1.3.1 This specification does not include any specific design criteria for medical face masks; however, surgical masks are differentiated by having ties to allow adjustment of the medical face mask fit in comparison to procedure or isolation masks, which use ear loops to affix the mask to the wearer's face.
1.4 This specification does not address requirements for regulated respiratory protection devices such as respirators, which may be necessary for some healthcare services and exposure to inhalation hazards.
... |
|
| Extent of Recognition
|
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| FDA recognition of ASTM F2100-19 [Rec# 6-425] will be superseded by recognition of ASTM F2100-23 [Rec# 6-492].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
|
| Standards Development Organization
|
FDA Specialty Task Group (STG)
| General Plastic Surgery/General Hospital |
|
| *These are provided as examples and others may be applicable. |
