BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇩 Indonesia

    STERILE POWDER FREE LATEX SURGICAL GLOVE WITH POLYMER COATING

    K Number: K031670 · Decision Sep 23, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    3
    Review Days
    117

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    Basic Information

    Device Name
    STERILE POWDER FREE LATEX SURGICAL GLOVE WITH POLYMER COATING
    K Number
    K031670
    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
    May 29, 2003
    Decision Date
    September 23, 2003
    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
    K031669 STERILE POWDER FREE SYNTHETIC SURGICAL GLOVE WITH POLYMER COATING
    K945363 MEDI PLUS SURGEON'S GLOVES