# K182766: Cufitec Surgical Mask

- Pathway: 510(k) (Traditional)
- Applicant: Nbc Meshtec, Inc.
- Decided: Jan 3, 2019 after 97 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
Longest line of descent: 5 generations back to K970835 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101128: Biofriend Biomask Surgical Facemask, Models Universal BF-200-2001 and Premium BF-200-3013, Filligent Limited (2011) Summary page 4.

## Indications for use
The Cufitec Surgical Mask is a single-use, disposable surgical mask to cover the nose and mouth of the wearer to protect from the transfer of microorganisms, body fluids and particulates and has an anti-influenza agent (active ingredient: Cul at 0.5% wt. concentration) on the outer and inner mask layers. The Cufitec Surgical Mask inactivates 99.99% of the following influenza viruses on five minutes contact with the surface of the facemask in laboratory (in vitro) tests against the following influenza viruses: Influenza A/HIN1: A/WS/33, A/Virginia/ATCC2/2009; Influenza A/H3N2: A/Kitakyusyu/159/93, A/Udorn/307/72, A/Hong Kong/8/68, A/Victoria/210/09, A/Virginia/ATCC6/2012; Influenza B: B/Lee/40, B/Taiwan/2/62; under tested contact conditions. Correlations between in vitro testing results and any clinical event has not been tested.

Source page: https://510kreport.com/device/K182766
Methodology: https://510kreport.com/methodology