510(k) K231741
K231741 is an FDA 510(k) premarket notification submitted by Prestige Ameritech for the device "ProGear® Surgical Mask with Oxafence®, Model AV82030". The FDA issued a decision of Substantially Equivalent on September 5, 2024. The device falls under product code OUK (Surgical Mask With Antimicrobial/Antiviral Agent), a Class II device regulated under 21 CFR 878.4040. Prestige Ameritech has at least 5 other 510(k) clearances on record.
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.