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510(k) Data Aggregation

    K Number
    K063777
    Device Name
    ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE
    Manufacturer
    BRIGHT ELEMENT SDN BHD
    Date Cleared
    2007-02-23

    (63 days)

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

    ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE

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

    A patient examination Nitrile Blue Powder Free Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

    Device Description

    NITRILE BLUE POWDER FREE EXAMINATION GLOVE

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a Nitrile Blue Powder Free Examination Glove. It is a regulatory document and does not contain information about the acceptance criteria, study details, or performance of a device in the context of AI/ML or medical imaging analysis as implied by your detailed request.

    The document discusses:

    • The FDA's review of a premarket notification for a medical glove.
    • The determination of substantial equivalence to a legally marketed predicate device.
    • General controls and regulations applicable to the device.
    • The intended use of the glove as a disposable device to prevent contamination between patient and examiner.

    Therefore, I cannot extract the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, or multi-reader multi-case studies, as this information is not present in the provided text.

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