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510(k) Data Aggregation

    K Number
    K041391
    Device Name
    FREEFORM BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
    Manufacturer
    HARTALEGA SDN BHD
    Date Cleared
    2004-07-09

    (45 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

    The nitrile examination glove is a disposable device intended and dental purposes that The mirrite examiner's hand to prevent contamination between the patient and examiner.

    Device Description

    FreeForm Blue Powder Free Nitrile Examination Gloves (Cornflower Blue)

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for "FreeForm Blue Powder Free Nitrile Examination Glove". It does not contain information about the acceptance criteria, study details, or performance of a device in the context of AI/ML or medical imaging studies as outlined in your request.

    Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details.

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