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

    POWDER FREE LATEX EXAMINATION GLOVES

    K Number: K990686 · Decision May 4, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    169
    Registration Numbers
    169
    Same Product Code
    1953
    Applicant Total
    2
    Review Days
    62

    Basic Information

    Device Name
    POWDER FREE LATEX EXAMINATION GLOVES
    K Number
    K990686
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    TOWER RUBBER INDUSTRIES SDN. BHD.
    Date Received
    March 3, 1999
    Decision Date
    May 4, 1999
    Product Code
    LYY
    Advisory Committee
    General Hospital
    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
    LYY Latex Patient Examination Glove

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    Other Clearances by TOWER RUBBER INDUSTRIES SDN. BHD.

    K Number Device Name
    K894979 LATEX PATIENT EXAMINATION GLOVES