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510(k) Data Aggregation

    K Number
    K043149
    Device Name
    FIRSTLINE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE-STEEL BLUE COLOR)
    Manufacturer
    FIRSTLINE, LLC.
    Date Cleared
    2005-05-25

    (191 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIRSTLINE, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    FirstLine Brand Double Polymer Coated Nitrile Examination Gloves (Powder Free – Steel Blue Color) is a disposable patient examination glove that is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Double Polymer Coated, Nitrile Examination Gloves (Powder-Free, Non-Sterile, Steel-Blue Color)
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