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510(k) Data Aggregation

    K Number
    K163126
    Device Name
    Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue)
    Manufacturer
    Blue Sail Medical Co., Ltd
    Date Cleared
    2017-02-22

    (106 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 (Blue, White, Blue, Cobalt blue) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt Blue)

    AI/ML Overview

    Please provide the text that describes the acceptance criteria and the study that proves the device meets the acceptance criteria. The document you provided is an FDA 510(k) clearance letter for examination gloves, which details regulatory information and indications for use, but does not contain a study plan or results demonstrating performance against specific acceptance criteria for a medical device's functionality (e.g., an AI/ML diagnostic tool).

    Therefore, based on the provided text, I cannot extract the information required to answer your questions about acceptance criteria and study results.

    If you can provide a document that contains information about a performance study for a medical device (especially one involving AI or a diagnostic tool), I would be happy to help you extract the requested details.

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