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510(k) Data Aggregation

    K Number
    K092200
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVES, ORANGE (ORANGE SCENTED), WHITE (VANILLA SCENTED)
    Manufacturer
    GX CORPORATION SDN BHD
    Date Cleared
    2009-09-16

    (56 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, ORANGE (ORANGE SCENTED), WHITE (VANILLA SCENTED)

    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 Scented, Orange Powder Free Nitrile Examination Gloves, Vanilla Scented, White

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA regarding "Powder Free Nitrile Examination Gloves." This document announces the substantial equivalence of the device to legally marketed predicate devices.

    It does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, ground truth, experts), MRMC studies, standalone performance, or training set information for an AI/ML device. The letter pertains to a simple medical device (gloves) and not an AI/ML system.

    Therefore, I cannot provide the requested information based on the input document.

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