K231741
- 510(k) number
- K231741
- Device name
- ProGear® Surgical Mask with Oxafence®, Model AV82030
- Applicant
- Prestige Ameritech TX · US
- Product code
- OUK — Surgical Mask With Antimicrobial/Antiviral Agent
- Decision date
- 2024-09-05
- Date received
- 2023-06-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K231741
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.