BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇲🇾 Malaysia

    STERILE EXTRA PROTECION SURGEON'S GLOVES

    K Number: K922979 · Decision Jan 18, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    1
    Review Days
    940

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    Basic Information

    Device Name
    STERILE EXTRA PROTECION SURGEON'S GLOVES
    K Number
    K922979
    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
    Ansell Malaysia Sdn Bhd
    Date Received
    June 22, 1992
    Decision Date
    January 18, 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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