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510(k) Data Aggregation

    K Number
    K110621
    Device Name
    SHENGKUN CHEMICAL
    Manufacturer
    ZIBO SHENGKUN CHEMICAL INDUSTRIAL CO., LTD
    Date Cleared
    2011-08-24

    (174 days)

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

    ZIBO SHENGKUN CHEMICAL INDUSTRIAL CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Synthetic Vinyl Examination Glove, Powder Free 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
    Synthetic Vinyl Examination Gloves, Powder-Free
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