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510(k) Data Aggregation

    K Number
    K961044
    Device Name
    NOVIGUARD QUICK DRY
    Date Cleared
    1997-07-03

    (476 days)

    Product Code
    Regulation Number
    880.6890
    Why did this record match?
    Applicant Name (Manufacturer) :

    **DR. NOVIS SMITH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Noviguard is a general purpose disinfectant and is intended to be used on non-critical surfaces such as floors, walls, counter tops, tables, associations and chairs and medical beds in health care facilities.
    Device Description
    Noviguard Quick Dry is a specially formulated general purpose disinfectant based on phenol and ortho phenol which are complexed reversibly with a olely/trimethylenediamine (Adogen 572) and another basic polymer(PVP) to form a thin film which contains a high concentration of the phenolic disinfectant when dried. (This permits the use of low levels of phenol in the use solution to be about 0.5% yet when the very thin film dries the percentage of phenol is about 25% as the complex.) The phenol is retained and escapes as if in a slow release situation over week or more. the higher molecular weight components which also are disinfectants remain and maintain an effective disinfecting barrier. This whole formulation is dissolved in ethanol which permits the solution to dry within seconds for fast even application to surfaces. Ethanol does not attack most normally found surfaces in homes or hospitals.
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