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510(k) Data Aggregation

    K Number
    K211457
    Device Name
    Powder Free Nitrile Examination Gloves (Blue, Black, Indigo)
    Manufacturer
    Ammex Corporation
    Date Cleared
    2021-12-18

    (221 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ammex Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) is a disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and examiner.
    Device Description
    The proposed device, Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size and color. The colors of the proposed device are Blue, Black, and Indigo.
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