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510(k) Data Aggregation

    K Number
    K232008
    Device Name
    Disposable Medical Examination Nitrile Gloves
    Manufacturer
    Raxwell Industrial LLC
    Date Cleared
    2023-08-08

    (33 days)

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

    Raxwell Industrial LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Medical Examination Nitrile Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
    Device Description
    Disposable Medical Examination Nitrile Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove is in black color, non-sterile and can be available in six specifications: XS, S, M, L, XL, XXL. It meets all of the requirements of ASTM standard D6319-19.
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