# K122702: Biofriend Biomask N95 Surgical Respirator

- Pathway: 510(k) (Traditional)
- Applicant: Filligent Limited
- Decided: Mar 18, 2013 after 195 days
- Product code: ONT (N95 Respirator 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). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 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 2.
- K063023: 3M Health Care Particulate Respirator and Surgical Mask, Model 1870, 3M Company (2007) Summary page 2.

## Most influential descendants
- K150729: SpectraShield 9500 Surgical N95 Respirator (2015), 0 descendants of its own

## Indications for use
The BioFriend BioMask N95 surgical respirator is a single use NIOSH-approved, disposable N95 surgical respirator with a hydrophilic plastic coating on the outer layer (active ingredient: citric acid 2% w/w, a pH-lowering agent), and a second inner layer treated with metal ions (active ingredients: copper 1.6% w/w and zinc 1.6% w/w which form ionic bonds with negatively-charged side-groups on influenza viruses). The BioFriend BioMask N95 surgical respirator inactivates 99.99% of tested influenza viruses on five minutes contact with the surface of the respirator in laboratory (in vitro) tests against the following seasonal, pandemic, avian, swine and equine influenza viruses: Influenza A subtypes and strains H1N1 (the 2009 pandemic flu subtype A/California/04/2009, A/Brisbane/59/2007, A/Wisconsin/10/1998, A/New Jersey/8/1976, A/Puerto Rico/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), under tested contact conditions. Correlation between in vitro testing results and any clinical event has not been tested. The BioFriend BioMask N95 surgical respirator, Model: Professional BF-200-3013AN is flat-folded and expands into a convex-shaped mask with polyamide/spandex elastic head-loops to secure the mask to the user's face, and a malleable aluminum strip positioned above the nose for a tighter seal around the nose and face. The device is intended to be worn during seasonal Influenza A or Influenza B, and an Influenza A or Influenza B pandemic. It is intended for occupational use, to help reduce wearer exposure to pathogenic biological airborne particulates, and to protect against the transfer of micro-organisms, body fluids, and particulate material.

Source page: https://510kreport.com/device/K122702
Methodology: https://510kreport.com/methodology