# K101128: Biofriend Biomask Surgical Facemask, Models Universal BF-200-2001 and Premium BF-200-3013

- Pathway: 510(k) (Traditional)
- Applicant: Filligent Limited
- Decided: May 26, 2011 after 399 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: 4 generations back to K970835 (1997). 4 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061716: Prestige Ameritech Face Mask, Prestige Ameritech (2006) Summary page 1.

## Most influential descendants
- K122702: Biofriend Biomask N95 Surgical Respirator (2013), 1 descendant of its own
- K192105: Innonix Antiviral Child's Face Mask (2019), 0 descendants of its own
- K182766: Cufitec Surgical Mask (2019), 0 descendants of its own
- K150729: SpectraShield 9500 Surgical N95 Respirator (2015), 0 descendants of its own

## Indications for use
The BioFriendTM BioMaskTM surgical facemasks are single use disposable devices 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 BioFriendTM BioMaskTM surgical facemasks inactivate 99.99% of Influenza viruses on five minutes 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: HiNi (the 2009 pandemnic flu subtype N/California/07/09, A/Brisbane/59/2007, A/Wisconsin/i 0/98, A/New Jersey/8/76, A/PR/8/38), H3N2 (A/Brisbane/i 0/2007,A/Wisconsin/67/2005,), H2N2 (A/2/JAPAN/305/57); the bird flu subtypes: H5N1 (NIBRG-14), H9N2 (AfTurkeyWisconsin/1966), H5N2 (A/Duck/PA/10218/84); the swine flu subtype: HiNi (A/Swine/1976/31); the equine flu subtype: H3N8 (N/Equine/2/Miami/63); and Influenza B strains: (B/Florida/4/2006, B/Lee/40), under tested contact conditions. Correlation between in vitro testing results and any clinical event has not been tested. There are two models: (1) Universal (BF-200-2001 A) - a standard flat mask with pleats; (2) Premium (BF-200-301 3A) - flat-folded and expanding into a convex-shaped mask with ear adjusters and an anti-fog nose flap. No clinical studies have been conducted comparing the ability of an untreated facemask and these facemasks to protect the wearer from Influenza infection. They are intended to be worn by operating room personnel during surgical procedures, to protect both the surgical patient, and the operating room personnel, from the transfer of microorganisms, body fluids and particulate material.

Source page: https://510kreport.com/device/K101128
Methodology: https://510kreport.com/methodology