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510(k) Data Aggregation

    K Number
    K013560
    Device Name
    SEMPERMED SUPREME, SIZES 5.5, 6, 6.5, 7, 7.5, 8, 8.5, AND 9
    Manufacturer
    SEMPERIT TECHNISCHE PRODUKTE GESELLSHAFT
    Date Cleared
    2002-01-16

    (82 days)

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

    SEMPERIT TECHNISCHE PRODUKTE GESELLSHAFT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. (21CFR 878.4460)
    Device Description
    sempermed® SUPREME is a sterile powder-free surgeon's glove. It is a disposable device made of natural rubber inside coated with a layer of polyurethane derivatives, and butadiene-based copolymer cross-linked by polyacrylates- free of process, siliconized. This glove is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. Water soluble protein less than 50 ug/dm2
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    K Number
    K012819
    Device Name
    SEMPERMED DERMA PLUS, SIZES 5.5,6,6.5,7,7.5,8,8.5,9
    Manufacturer
    SEMPERIT TECHNISCHE PRODUKTE GESELLSHAFT
    Date Cleared
    2001-11-16

    (85 days)

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

    SEMPERIT TECHNISCHE PRODUKTE GESELLSHAFT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. (21CFR 878.4460)
    Device Description
    sempermed® DERMA plus is a powdered surgeon's glove and it is a disposable device made of natural rubber inside coated with synthetic latex material that bears powder to facilitate donning and it is intended to be worn on the hands usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. The glove is powdered with absorbable dusting powder USP Grade
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    K Number
    K981096
    Device Name
    SEMPERMED SURGEONS' GLOVES - SUPREME
    Manufacturer
    SEMPERIT TECHNISCHE PRODUKTE GESELLSHAFT
    Date Cleared
    1998-10-29

    (218 days)

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

    SEMPERIT TECHNISCHE PRODUKTE GESELLSHAFT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This medical glove is worn on the hand of surgeons, nurses and similar personnel to prevent contamination between health care personnel and the patient.
    Device Description
    Latex patient surgeons 'gloves powderfree
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