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510(k) Data Aggregation

    K Number
    K080066
    Device Name
    VFLEX POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK, AND GRAY COLOR)
    Manufacturer
    GX CORPORATION SDN BHD
    Date Cleared
    2008-03-05

    (55 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

    Device Description

    VFlex, Powder Free Nitrile Examination Gloves, Blue, White, Pink and Gray Color

    AI/ML Overview

    The provided text is a letter from the FDA regarding a 510(k) premarket notification for "VFlex, Powder Free Nitrile Examination Gloves." It confirms the substantial equivalence of the device to legally marketed predicate devices and outlines general regulatory requirements.

    However, the document does NOT contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies.

    The letter is a regulatory approval document, not a scientific study report. Therefore, I cannot extract the requested information from the provided text.

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