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510(k) Data Aggregation

    K Number
    K191860
    Device Name
    Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential
    Manufacturer
    Semperit Technische Produkte Gesellchaft m.b.H.
    Date Cleared
    2020-03-31

    (264 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    Semperit Technische Produkte Gesellchaft m.b.H.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Sterile Powder-Free Synthetic Rubber Surgeon's Glove with Low Dermatitis Potential is a single use disposable device intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Device Description
    Sterile Powder-Free Synthetic Rubber Surgeon's Glove with Low Dermatitis Potential
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