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510(k) Data Aggregation

    K Number
    K023159
    Device Name
    MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POEDER FREE
    Manufacturer
    INDUSTRIAL CLOTHINGS, LTD.
    Date Cleared
    2002-11-12

    (50 days)

    Product Code
    LYY
    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

    Midas Touch™ Blue Latex Examination Gloves - Powder free, is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.

    Device Description

    Midas Touch™ Blue Latex Examination Gloves – Powder free

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for examination gloves. This type of document does not describe acceptance criteria, study details, or performance metrics for AI/ML-driven devices.

    Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for training or test sets.

    The document confirms the device (Midas Touch™ Blue Latex Examination Gloves, Powder Free) is substantially equivalent to legally marketed predicate devices, meaning it meets the general controls provisions for Class I devices. The indications for use are described as: "a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner." This is a regulatory assessment for a physical medical device, not an AI/ML software device.

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