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

    SAFEMED LATEX SURGICAL GLOVES

    K Number: K914097 · Decision Aug 14, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    3
    Review Days
    337

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    Basic Information

    Device Name
    SAFEMED LATEX SURGICAL GLOVES
    K Number
    K914097
    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
    Safetytech Sdn. Bhd.
    Date Received
    September 12, 1991
    Decision Date
    August 14, 1992
    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 Safetytech Sdn. Bhd.

    K Number Device Name
    K925537 POWDER-FREE LATEX EXAMINATION GLOVES
    K893279 LATEX EXAMINATION GLOVES