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510(k) Data Aggregation

    K Number
    K070096
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, WHITE, PINK, BLACK AND GRAY COLOR
    Manufacturer
    GX CORPORATION SDN BHD
    Date Cleared
    2007-03-14

    (63 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

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

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding "Powder Free Nitrile Examination Gloves." This document does not describe the acceptance criteria or a study proving that a device meets acceptance criteria. Instead, it is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

    Therefore, I cannot extract the requested information from the provided text. The document is about regulatory approval, not device performance studies.

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