# K192105: Innonix Antiviral Child's Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Innonix Technologies Limited
- Decided: Nov 29, 2019 after 116 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 Innonix Anti-Influenza Child’s Face Mask (Models BF-200-3015A and BF-200-2005A) is a single use, disposable device that is intended to be worn by children (recommended ages 5-10) to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms, body fluid and particulate materials. The mask is specifically for child or pediatric patients to provide protection for the respiratory tract. This face mask is recommended for use in a healthcare setting with appropriate adult supervision. The Innonix Anti-Influenza Child’s Face Mask has hydrophilic plastic coating (active ingredient: citric acid 2%, a pH lowering agent) that rapidly absorbs aerosol droplets away from the outer surface of the mask and a second inner layer treated with metal ions (active ingredients: copper 1.6% and zinc 1.6%) that inactivate influenza viruses. The Innonix Anti-Influenza Child’s Face Mask inactivated 99.99% of tested influenza viruses (≥4 log difference versus identical untreated control mask textiles) within five minutes of contact with the surface of the facemask in laboratory (in vitro) tests against the following seasonal, pandemic, avian, swine and equine influenza viruses: Influenza A subtypes and strains H1N1 (A/California/04/2009, A/Brisbane/59/2007, A/Wisconsin/10/1998, A/New Jersey/8/1976, A/PuertoRico/8/1934), H3N2 (A/Brisbane/10/2007, A/Wisconsin/67/2005), H2N2 (A/2/Japan/305/1957); the bird flu subtypes: H5N1 (NIBRG-14), H9N2 (A/Turkey/Wisconsin/1966), H5N2 (A/Duck/PA/10218/84); the swine flu subtype: H1N1 (A/Swine/1976/1931); the equine flu subtype: H3N8 (A/Equine/2/Miami/1963); and Influenza B strains: (B/Florida/4/2006, B/Lee/1940). The mask also inactivated >99.99% of Measles virus strain ATCC VR-24 and Coronavirus 229E strain ATCC VR-740 within one minute of contact with the surface of the facemask in laboratory in vitro tests. Correlation between in vitro results and any clinical event has not been tested.

Source page: https://510kreport.com/device/K192105
Methodology: https://510kreport.com/methodology