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510(k) Data Aggregation

    K Number
    K111134
    Device Name
    NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
    Manufacturer
    SIEM AEMPEMED CORP., LTD
    Date Cleared
    2012-01-26

    (279 days)

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

    SIEM AEMPEMED CORP., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Non sterile, Powder free Nitrile Examination Glove, Blue.
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