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510(k) Data Aggregation

    K Number
    K231741
    Device Name
    ProGear® Surgical Mask with Oxafence®, Model AV82030
    Manufacturer
    Prestige Ameritech
    Date Cleared
    2024-09-05

    (449 days)

    Product Code
    OUK
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    OUK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ProGear® Surgical Mask with Oxafence® is a single-use, disposable device used to cover the nose and mouth of the wearer to protect from transfer of microorganisms, body fluids and particulates. The outer layer of the face mask is coated with methylene blue (0.47 micrograms per square cm area). The ProGear® Surgical Mask with Oxafence® inactivates of the following test viruses after five minutes of contact with the treated surface of the face mask in laboratory (in vitro) tests under a lighting intensity of 500 ± 25 lux. Influenza A/PR/8/34/H1N1 (TC adapted, ATCC VR-1469), 3-log or 99.9% inactivation Betacoronavirus 1 OC43 (ATCC VR-1558), 4-log or 99.99% inactivation Feline Calicivirus F-9 (ATCC VR- 782), 4-log or 99.99% inactivation Antiviral efficacy on other viruses has not been evaluated. Correlations between in vitro testing results and any clinical event have not been evaluated.
    Device Description
    The ProGear® Surgical Mask with Oxafence® is a single-use, disposable device used to cover the nose and mouth of the wearer to protect from transfer of microorganisms, body fluids and particulates. The outer layer of the face mask is coated with methylene blue (0.47 micrograms per square cm area).
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    K Number
    K192105
    Device Name
    Innonix Antiviral Child's Face Mask
    Manufacturer
    Innonix Technologies Limited
    Date Cleared
    2019-11-29

    (116 days)

    Product Code
    OUK, OXZ
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    OUK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Innonix Anti-Influenza Child's Face Mask (Models BF-200-3015A 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 pediatic patients to provide protection for the respiratory tract. This face mask is recommended for use in a healthcare setting with appropriate adult supervision. The Influenza Child's Face Mask has hydrophilic plastic coating (active ingredient: citric acid 2%, a pH lowering agent) that rapidly absorbs away from the outer surface of the mask and a second inner layer treated with metal ions (active ingredients: copper 1.6%) that inactivate influenza viruses.
    Device Description
    The Innonix Anti-Influenza Child's Face Masks, (both Model BF-200-3015A and BF-200-2005A) comprise 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-bond polypropylene. All of the construction materials used in this device are typical construction materials commonly used in surgical facemasks and being used in current legally marketed devices, and are not made with natural rubber latex. The outer active layer of the face mask is coated with a hydrophilic plastic containing citric acid. The second inner layer is treated with copper and zinc ions. Both of these layers inactivate influenza viruses using different mechanisms of action (pH lowering and ionic disruption). Model: BF-200-3015A is flat-folded and expands into a convex-shaped mask with polyamide/spandex elastic ear-loops to secure the mask to the user's face, and has a malleable aluminum strip covered with polyurethane foam positioned above the nose for a tighter seal around the nose and face. Model: BF-200-2005A is a flat pleated mask with polyamide/spandex elastic ear-loops to secure the mask to the user's face, and has a malleable aluminum strip covered with polyurethane foam positioned above the nose for a tighter seal around the nose and face.
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    K Number
    K182766
    Device Name
    Cufitec Surgical Mask
    Manufacturer
    NBC Meshtec Inc.
    Date Cleared
    2019-01-03

    (97 days)

    Product Code
    OUK
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    OUK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended 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 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 99.90% 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/H1N1: 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.
    Device Description
    The Cufitec® Surgical Mask is a single-use, disposable device, provided non-sterile, and is intended to cover the nose and mouth of the wearer to protect from the transfer of microorganisms, body fluids, and particulates and has an added anti-influenza agent which inactivates specific pathogens under specified contact conditions. The mask is comprised of four layers of materials: rayon layers with added anti-influenza coating (outer and inner layers) and polypropylene layers (two middle layers). All of the construction materials used in this device are commonly used in the construction of surgical facemasks used in current legally marketed devices. The inner and outer layers are coated with an anti-influenza agent (CuI, 0.5% wt.), which inactivates influenza viruses under tested contact conditions using the same mechanism of action. Masks are held in place on the wearer with ear loops (polyurethane and nylon) and contains a malleable polyethylene nosepiece strip to conform to the wearer's face.
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    K Number
    K101128
    Device Name
    BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013
    Manufacturer
    FILLIGENT LIMITED
    Date Cleared
    2011-05-26

    (399 days)

    Product Code
    OUK
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    OUK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    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.
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