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510(k) Data Aggregation

    K Number
    K021465
    Device Name
    MIDAS TOUCH LATEX EXAMINATION GLOVES-POLYMER COATED, POWDER FREE
    Manufacturer
    INDUSTRIAL CLOTHINGS, LTD.
    Date Cleared
    2002-05-22

    (15 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™ Latex Examination Gloves- Polymer coated, 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™ Latex Examination Gloves- Polymer coated, Powder free WITH PROTEIN LABELING CLAIM (100 mic

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for medical examination gloves. It does not describe a study or acceptance criteria for a device in the context of AI/ML performance. Instead, it concerns the substantial equivalence of a physical medical device (gloves) to a predicate device.

    Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or expert qualifications as these concepts are not applicable to the content of this document.

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