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

    SAFETEX/SUNTEX STERILE SURGICAL LATEX GLOVES

    K Number: K900296 · Decision Mar 14, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    556
    Applicant Total
    3
    Review Days
    51

    Basic Information

    Device Name
    SAFETEX/SUNTEX STERILE SURGICAL LATEX GLOVES
    K Number
    K900296
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    P.T. LATEXINDO PRAUTAMA
    Date Received
    January 22, 1990
    Decision Date
    March 14, 1990
    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. LATEXINDO PRAUTAMA

    K Number Device Name
    K910631 SUNTEX STERILE EXAM GLOVES
    K892478 SAFETEX & SUNTEX PATIENT EXAMINATION GLOVES