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

    SANOFLEX-STERILE LATEX SURGICAL GLOVES

    K Number: K903513 · Decision Sep 14, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    4
    Review Days
    42

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    Basic Information

    Device Name
    SANOFLEX-STERILE LATEX SURGICAL GLOVES
    K Number
    K903513
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Lowenkamp Intl., Inc.
    Date Received
    August 3, 1990
    Decision Date
    September 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 Lowenkamp Intl., Inc.

    K Number Device Name
    K951940 PATIENT EXAMINATION GLOVE
    K946154 MALA LATEX EXAM GLOVES AND SCAN-SUB
    K910439 FOXELL PLUS MULTIPLE (PERSONAL TOUCH TM)