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510(k) Data Aggregation

    K Number
    K990541
    Device Name
    BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE)
    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 (Powder Free) 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 Gloves (Powder Free)

    AI/ML Overview

    Please note that the provided document is a 510(k) clearance letter from the FDA for medical gloves, not a study report for an AI device. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria and a study proving device performance for an AI system.

    The document discusses the classification of "Brightway™ Brand Nitrile Examination Glove (Powder-Free)" as a Class I regulatory device and its substantial equivalence to previously marketed devices. It outlines general controls provisions for such devices, including good manufacturing practices, labeling, and prohibitions against misbranding.

    Therefore, I cannot extract the information required in your request from the provided text.

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