BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATING

    K Number: K111868 · Decision Sep 21, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    5
    Review Days
    82

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    Basic Information

    Device Name
    STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATING
    K Number
    K111868
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardinal Health-Medical Products and Services
    Date Received
    July 1, 2011
    Decision Date
    September 21, 2011
    Product Code
    KGO
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KGO Surgeon'S Gloves

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    Other Clearances by Cardinal Health-Medical Products and Services

    K Number Device Name
    K132060 DURABLUE STERILIZATION WRAP
    K123289 DURABLUE STERILIZATION WRAP
    K120542 CARDINAL HEALTH DURABLUE STERILIZATION WRAP
    K113707 STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING