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510(k) Data Aggregation

    K Number
    K990542
    Device Name
    BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)
    Manufacturer
    BRIGHTWAY HOLDINGS SDN. BHD.
    Date Cleared
    1999-04-09

    (46 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

    Brightway™ Brand Nitrile Examination Glove (Powdered) is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.

    Device Description

    Brightway™ Brand Nitrile Examination Glove (Powdered)

    AI/ML Overview

    I am sorry, but based on the provided document, the information required to answer your request is not present. The document is a 510(k) clearance letter for "Brightway™ Brand Nitrile Examination Glove (Powdered)" and contains regulatory information about the device's classification and marketing authorization. It does not include details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications for AI/ML device evaluation.

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