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    K Number
    K170393
    Device Name
    Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue)
    Manufacturer
    Zibo Chengxun Automatic Device Co., Ltd
    Date Cleared
    2017-05-09

    (90 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    Hematology (HO)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

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

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

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

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested. The document is a 510(k) premarket notification letter from the FDA to Zibo Chengxun Automatic Device Co., Ltd regarding Powder Free Nitrile Examination Gloves. It primarily discusses the substantial equivalence determination for the device and regulatory compliance.

    It does not include details about:

    1. Acceptance criteria and reported device performance.
    2. Sample sizes, data provenance, number of experts, adjudication methods for ground truth, or details of any comparative effectiveness studies (MRMC or standalone).
    3. The type or establishment of ground truth for testing or training sets.
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