510(k) K231741
- Device
- ProGear® Surgical Mask with Oxafence®, Model AV82030
- Applicant
- Prestige Ameritech
- 510(k) number
- K231741
- Product code
- OUK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-09-05
- Date received
- 2023-06-14
- Regulation
- 878.4040
- Classification name
- Surgical Mask With Antimicrobial/Antiviral Agent
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Hofheinz Danica
- Address
- 7201 Iron Horse Blvd. North Richland Hills TX US 76180 76180
FDA Registration Numbers#
- 3013152643
- 3005022483
- 3003495693
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code OUK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K192105 | Innonix Antiviral Child's Face Mask | Innonix Technologies Limited | 2019-11-29 |
| K182766 | Cufitec Surgical Mask | Nbc Meshtec, Inc. | 2019-01-03 |
| K101128 | BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013 | Filligent Limited | 2011-05-26 |