# K231741: ProGear® Surgical Mask with Oxafence®, Model AV82030

- Pathway: 510(k) (Traditional)
- Applicant: Prestige Ameritech
- Decided: Sep 5, 2024 after 449 days
- Product code: OUK (Surgical Mask With Antimicrobial/Antiviral Agent)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The ProGear® Surgical Mask with Oxafence® is a single-use, disposable device used to cover the nose and mouth of the wearer to protect from transfer of microorganisms, body fluids and particulates. The outer layer of the face mask 1s coated with methylene blue (0.47 micrograms per square cm area). The ProGear® Surgical Mask with Oxafence® inactivates single isolates of the following test viruses after five minutes of contact with the treated surface of the face mask in laboratory (in vitro) tests under a lighting intensity of 500 + 25 lux. Influenza A/PR/8/34/HIN1 (TC adapted, ATCC VR-1469), 3-log or 99.9% inactivation Betacoronavirus 1 OC43 (ATCC VR-1558), 4-log or 99.99% inactivation Feline Calicivirus F-9 (ATCC VR- 782), 4-log or 99.99% 1inactivation Antiviral efficacy on other viruses has not been evaluated. Correlations between 1n vitro testing results and any clinical event have not been evaluated.

Source page: https://510kreport.com/device/K231741
Methodology: https://510kreport.com/methodology