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

    MEDI PLUS SURGEON'S GLOVES

    K Number: K945363 · Decision Mar 7, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    3
    Review Days
    139

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    Basic Information

    Device Name
    MEDI PLUS SURGEON'S GLOVES
    K Number
    K945363
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    P.T. Saptindo Surgica
    Date Received
    October 19, 1994
    Decision Date
    March 7, 1995
    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 P.T. Saptindo Surgica

    K Number Device Name
    K031670 STERILE POWDER FREE LATEX SURGICAL GLOVE WITH POLYMER COATING
    K031669 STERILE POWDER FREE SYNTHETIC SURGICAL GLOVE WITH POLYMER COATING