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510(k) Data Aggregation

    K Number
    K182612
    Device Name
    Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue and Violet Blue)
    Manufacturer
    Zibo Yahao Supplies Co., LTD
    Date Cleared
    2019-05-10

    (231 days)

    Product Code
    LZA
    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 powder Free Nitrile Examination Gloves(Cobalt Blue,Black,Blue) is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    The powder Free Nitrile Examination Gloves(Cobalt Blue,Black,Blue and Violet Blue)

    AI/ML Overview

    I am sorry, but the provided text from the FDA letter (K182612 for Powder Free Nitrile Examination Gloves) does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, or any of the detailed data typically associated with the efficacy or performance validation of an AI/ML-based medical device.

    The document is a 510(k) clearance letter for examination gloves, which are Class I medical devices subject to general controls and substantial equivalence determination. The review process for such devices focuses on manufacturing, labeling, and substantial equivalence to a legally marketed predicate device, rather than detailed performance studies like those required for advanced diagnostic or therapeutic devices that utilize AI/ML.

    Therefore, I cannot extract the requested information regarding acceptance criteria and study details from the provided text.

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