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510(k) Data Aggregation

    K Number
    K041913
    Device Name
    POWDERFREE COLORED AND FLAVORED CHLOREPRENE PATIENT EXAMINATION GLOVES TESTED FOR CHEMO USE
    Manufacturer
    PT. MEDISAFE TECHNOLOGIES
    Date Cleared
    2004-12-01

    (139 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 device is a disposable patient examination glove made of synthetic rubber intended for medical purposes. It is donned by the examiner on the hands to prevent possible contamination between patient and examiner (Tested for Chemo use).

    Device Description

    Powderfree Chloroprene White, Pink, Blue and Green Colored Patient Examination Gloves (FLAVOR Strawberry, Peppermint, Tutty-Frutti)

    AI/ML Overview

    The provided text is a clearance letter from the FDA for a patient examination glove and does not contain information about acceptance criteria or a study proving that a device meets such criteria. It primarily focuses on the substantial equivalence determination for marketing the device.

    Therefore, I cannot answer your request based on the provided input.

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