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510(k) Data Aggregation

    K Number
    K973615
    Device Name
    SKINGARD TPF/AOSSTEX TPF/SENSIFREE/ESSENTIAL TPF/AMERIGLO TPF LATEX EXAMINATION GLOVES
    Manufacturer
    MACRO RUBBER INDUSTRIAL, INC.
    Date Cleared
    1998-05-20

    (239 days)

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

    MACRO RUBBER INDUSTRIAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The fatex examination gloves are used in both the Medical & Dental Communities, to prevent contamination between patient and examiner.
    Device Description
    Latex examination gloves - ambidextrous
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