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510(k) Data Aggregation

    K Number
    K011924
    Device Name
    POWDERED BLUE NITRILE EXAMINATION GLOVES
    Manufacturer
    SELTOM PACIFIC SDN. BHD.
    Date Cleared
    2001-07-10

    (20 days)

    Product Code
    LZA
    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 glove 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

    Powdered Blue Nitrile Examination Gloves

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for "Powdered Blue Nitrile Examination Gloves." This document does not contain any information about the acceptance criteria or study results for a device that relies on algorithms or AI.

    The letter pertains to a physical medical device (examination gloves) and focuses on its substantial equivalence to a predicate device, as required for 510(k) clearance. Therefore, it does not include the type of information requested about artificial intelligence performance metrics, training sets, expert ground truth, or MRMC studies.

    To answer your request, I would need a document that describes the evaluation of an AI-powered medical device.

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