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510(k) Data Aggregation

    K Number
    K093189
    Device Name
    ACTIPROTECT UC N95 RESPIRATOR
    Date Cleared
    2010-07-02

    (266 days)

    Product Code
    Regulation Number
    880.6260
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    Product Code :

    ORW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Actiprotect™ UC N95 Respirator is a single use, disposable respirator coated with Virucoat™ on the outer layer (active ingredient: citric acid, 1.8%, a pH lowering agent) and is not an antiviral drug. Actiprotect kills (inactivates) 99.99% of Influenza A viruses (tested against Influenza A subtypes H1N1 (including 2009 pandemic strain)) within one minute of contact with the surface of the respirator. In vitro (laboratory) tests have demonstrated 99.99% kill (inactivation) on the surface of the outer laver of the respirator when tested in vitro against the following influenza A viruses (tested against Influenza A subtypes (and strains): H1N1(JPN/35/2007, JPN/36/2007, including 2009 pandemic strain: NYMC X-179A), H2N2 (A2/JP/305/57), H3N2 (Hong Kong 8/68, JPN/12/2007) and including bird flu subtypes: H5N1 (VNH5N1-PR8/CDCRG), H5N9 (Turkey A/Wisc/68, Myna A/Mass/71), and Influenza B strains (JPN/85/2007, JPN/128/2007, JPN/143/2007)) under tested contact conditions. No clinical studies have been conducted comparing the ability of an uncoated N95 respirator and this coated N95 respirator to protect the wearer from influenza infection. Actiprotect™ is intended for use by the general public in public health medical emergencies. Effectiveness tested against specific Influenza A and Influenza A pandemic strains. It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates. Actiprotect™ UC N95 Respirator also helps to protect the wearer from splash and spray of body fluids.
    Device Description
    Actiprotect™ UC N95 Respirator is a double strap, flat-fold style filtering facepiece respirator. It consists of multiple layers of non-woven fabric. A filtration layer provides a barrier to particles of various sizes through mechanical entrapment in a tortuous pathway and by surface attraction by electrostatic forces. The outer layer contains a coating to capture and inactivate viruses. The layers of non-woven fabric are ultrasonically sealed together at the outer perimeter. Two synthetic elastic straps are stapled or welded to the edge of the respirator and are used to secure the respirator to the user's face.
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