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510(k) Data Aggregation

    K Number
    K990668
    Device Name
    POWDER FREE BLUE NITRILE GLOVE
    Manufacturer
    TG MEDICAL SDN BHD
    Date Cleared
    1999-06-03

    (93 days)

    Product Code
    LZA,DAT
    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

    The glove is disposable and intended for Medical purpose that is worn on the examiner's hand to prevent contamination between the patient and the examiner.

    Device Description

    POWDER FREE BLUE NITRILE GLOVE

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA regarding "Powder Free Blue Nitrile Examination Glove". It primarily confirms that the device is substantially equivalent to legally marketed predicate devices.

    This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment for an AI/ML medical device.

    The information requested in the prompt (acceptance criteria, study details, expert involvement, etc.) is typically found in the technical documentation of a medical device submission, particularly for AI/ML devices, and is not part of this FDA clearance letter.

    Therefore, I cannot extract the requested information from the provided text.

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