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510(k) Data Aggregation

    K Number
    K103772
    Device Name
    VINYL EXAMINATION GLOVE POWDER FREE (CLEAR, NON-COLRED) /YELLOW/WHITE)
    Manufacturer
    ADVANCED MEDICAL DEVICES FACTORY
    Date Cleared
    2011-02-25

    (60 days)

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

    ADVANCED MEDICAL DEVICES FACTORY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A Stretch Vinyl examination glove, Powder Free(Clear(Non-Colored)/Yellow/White) 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
    Powder-Free, Stretch Vinyl Examination Gloves, Clear (Non-Colored) Yellow/White
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