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510(k) Data Aggregation

    K Number
    K080937
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVE, ORANGE
    Manufacturer
    GX CORPORATION SDN BHD
    Date Cleared
    2008-05-23

    (51 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, Orange

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding "Powder Free Examination Gloves, Orange." It establishes substantial equivalence for a medical device but does not contain information about acceptance criteria or a study proving device performance.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on equivalence to a predicate device, rather than detailed performance study results against specific acceptance criteria.

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