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510(k) Data Aggregation

    K Number
    K012710
    Device Name
    DISPOSABLE POWDERED VINYL EXAMINATION GLOVES
    Manufacturer
    SHIJIAZHUANG BRILLIANCE PLASTIC CO., LTD.
    Date Cleared
    2001-10-04

    (51 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 Powdered Vinyl Examination Gloves

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for "Disposable Powdered Vinyl Examination Gloves". This type of document is for a medical device that demonstrates substantial equivalence to a legally marketed predicate device, rather than a novel AI/ML-driven diagnostic device.

    Therefore, the specific information requested in the prompt about acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not applicable to this document. The FDA's determination for this device is based on demonstrating substantial equivalence to a predicate device, as outlined in the letter, rather than a clinical study with detailed performance metrics as would be required for an AI/ML diagnostic.

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