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510(k) Data Aggregation

    K Number
    K033229
    Device Name
    (MULTIPLE LABELS) POWDER-FREE VINYL EXAMINATION GLOVES
    Manufacturer
    BERNARD TECHNOLOGIES, INC.
    Date Cleared
    2003-12-17

    (72 days)

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

    BERNARD TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A powder-free patient examination glove is a disposable device made of synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
    Device Description
    Class II powder-free patient examination glove 80LYZ, that meets all of the requirements of ASTM standard D 5250-00.
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