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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/Californial04/2009, 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/TurkeyWisconsin/1966), H5N2 (A/Duck/PA/10218/84); the swine fly sublype: 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 flatfolded 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.

The BioFriend™ BioMask™ N95 surgical respirator, Model: Professional (BF-200-3013AN) is flatfolded 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 respirator is comprised of four layers of material: an outer layer of spun-bond polypropylene, a second layer of cellulose/polyester, a third layer of melt-blown polypropylene filter material and an inner (fourth) layer of spun-bound polypropylene. All of the construction materials used in this device are typical construction materials commonly used in surgical facemasks and N95 surgical respirators and being used in current legally marketed devices. The outer active layer of the respirator is coated with a hydrophilic plastic. The second inner layer is treated with copper and zinc ions. Both layers inactivate influenza viruses using different mechanisms of action.

The BioFriend™ BioMask™ 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 BioFriend™ BioMask™ 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: H1N1 (the 2009 pandemic flu subtype A/California/07/09, A/Brisbane/59/2007, A/Wisconsin/10/98, A/New Jersev/8/76. A/PR/8/38), A/PR/8/38 H3N2 (A/Brisbane/10/2007.A/Wisconsin/67/2005.). H2N2 (A/2JAPAN/305/57); 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/1976/31); the equine flu subtype: H3N8 (A/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-200-2001A) - a standard flat mask with pleats; (2) Premium (BF-200-3013A) - flat-folded and expanding into a convex-shaped mask with ear adjusters and an antifog 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.

The BioFriend™ BioMask™ surgical facemask is offered in two mask styles, Model: BF-200-2001A ("Universal") and Model: BF-200-3013A ("Premium"). The Universal model is a standard flat mask with pleats, while the Premium model is flat-folded and expands into a convex-shaped mask. The Premium model also has ear adjusters and an anti-fog nose flap. Both models are comprised of four layers of material: an outer layer of spun-bond polypropylene, a second layer of cellulose/polyester, a third layer of melt-blown polypropylene filter material and an inner (fourth) layer of spun-bound polypropylene. All of the construction materials used in these devices are typical construction materials commonly used in surgical facemasks and are being used in current legally marketed devices. The outer is coated with a hydrophilic plastic. The second inner layer is treated with copper and zinc. Both layers inactivate influenza viruses using different mechanisms of action. Masks are held in place on the wearer with elastic loops and contain a malleable metal nosepiece strip.