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510(k) Data Aggregation

    K Number
    K163041
    Device Name
    Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E
    Manufacturer
    PT. MEDISAFE TECHNOLOGIES
    Date Cleared
    2017-02-22

    (114 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

    Powder Free Polychloroprene Examination Gloves - Pink with Aloe Vera and Vitamin E

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding "Powder Free Polychloroprene Examination Gloves - Pink with Aloe Vera and Vitamin E." It does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria.

    The letter is a regulatory approval for marketing the device based on a determination of substantial equivalence to previously marketed devices. It confirms that the device is a Class I medical device (patient examination glove), lists general controls it must adhere to, and provides contact information for further regulatory inquiries.

    Therefore, I cannot provide the requested information as it is not present in the provided text.

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