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510(k) Data Aggregation

    K Number
    K113393
    Manufacturer
    Date Cleared
    2012-09-11

    (299 days)

    Product Code
    Regulation Number
    880.6250
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A Powder-free pateint examination glove 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

    Powder Free Black Nitrile Examination Gloves

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for Powder Free Black Nitrile Examination Gloves. It primarily discusses the regulatory classification and general controls for the device and confirms its substantial equivalence to a predicate device.

    It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or information about AI/ML models.

    Therefore, I cannot provide the requested information based on the input text.

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