510(k) K231741
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 5, 2024
- Date Received
- June 14, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Surgical Mask With Antimicrobial/Antiviral Agent
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type
A single use, disposable surgical mask for occupational use to cover the nose and mouth of the wearer to protect from the transfer of microorganisms,body fluids and particulates and has an added antimicrobial and/or antiviral agent which kills specific pathogens under specified contact conditions.