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510(k) Data Aggregation

    K Number
    K012711
    Device Name
    DISPOSABLE POWDER FREE VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    SHIJIAZHUANG BRILLIANCE PLASTIC CO., LTD.
    Date Cleared
    2001-09-18

    (35 days)

    Product Code
    LYZ
    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

    A patient examination gloves 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

    Disposable Powder Free Vinyl Patient Examination Gloves

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for "Disposable Powder Free Vinyl Patient Examination Gloves." It is not a study report or clinical trial document for a diagnostic AI device. Therefore, it does not contain the information required to answer your request regarding acceptance criteria, study details, ground truth, or sample sizes related to an AI device.

    The document discusses the substantial equivalence of the gloves to previously marketed predicate devices under the general controls provisions of the Federal Food, Drug, and Cosmetic Act.

    To answer your questions, I would need a document that describes a study performed on a medical AI device.

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