510(k) · Cleared
ClearedProGear® Surgical Mask with Oxafence®, Model AV82030
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prestige Ameritech · OUK Surgical Mask With Antimicrobial/Antiviral Agent
Cleared on Sep 5, 2024 after a 449-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 5, 2024
- Review
- 449 days
- Class
- Class II
- Product code
- OUK
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OUK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All OUK devicesOUK Surgical Mask With Antimicrobial/Antiviral Agent: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · OUK
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OUK
Too few OUK 510(k)s in any year since 2007 to give a median.
Recalls per year · OUK
No recall names OUK since 2007.
Adverse event reports per year · OUK
1in 2017
MAUDE reports naming product code OUK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (142 words)
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.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K231741 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231741: ProGear® Surgical Mask with Oxafence®, Model AV82030.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231741
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026