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510(k) Data Aggregation

    K Number
    K032024
    Device Name
    POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE COLOR (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
    Manufacturer
    SHEN WEI (USA), INC.
    Date Cleared
    2003-10-29

    (121 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    K101436
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

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

    This device is not intended to be used as a chemical barrier.

    Device Description

    Textured Powder-Free Nitrile Examination Glove, Blue Color Tested for Use with Chemotherapy Drug

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA regarding a medical device, which is a Textured Powder-Free Nitrile Examination Glove. It does not contain any information about acceptance criteria or a study that proves the device meets acceptance criteria in the context of an AI/ML device.

    The letter simply states that the FDA has reviewed the 510(k) submission and determined the device (the examination glove) is substantially equivalent to legally marketed predicate devices. This means it can proceed to market subject to general controls.

    Therefore, I cannot extract the requested information from this document. The document primarily focuses on the regulatory approval process for a physical medical product, not on the performance evaluation of an AI-powered medical device through studies with specific acceptance criteria.

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