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510(k) Data Aggregation

    K Number
    K070097
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR
    Manufacturer
    GX CORPORATION SDN BHD
    Date Cleared
    2007-03-23

    (72 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    POWDER FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR

    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, Peppermint Scented, Blue Color

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for Powder-Free Nitrile Examination Gloves. It does not contain any information about acceptance criteria or a study that proves a device meets such criteria.

    The letter is a regulatory document confirming that the device is substantially equivalent to a predicate device and can be marketed. It details the product name, regulation number, product code, and clarifies regulatory compliance requirements.

    Therefore, I cannot provide the requested information.

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