# OUK: Surgical Mask With Antimicrobial/Antiviral Agent

- Device class: 2; regulation: 21 CFR 878.4040; FDA's rule: 510(k) required
- FDA decisions: 4
- 510(k) review time 2021–2025: median 449 days (middle half 449–449)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2011: 1
- 2019: 2
- 2024: 1

## Most-cited predicates
- K101128: Biofriend Biomask Surgical Facemask, Models Universal BF-200-2001 and Premium BF-200-3013 (2011), cited by 3

Source page: https://510kreport.com/product-code/OUK
Data by year (CSV): https://510kreport.com/product-code/OUK.csv