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

    EXAMINATION GLOVES

    K Number: K890393 · Decision Aug 10, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    3
    Review Days
    197

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    Basic Information

    Device Name
    EXAMINATION GLOVES
    K Number
    K890393
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Sumirubber Industries (Kedah) Sdn. Bhd.
    Date Received
    January 25, 1989
    Decision Date
    August 10, 1989
    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 Sumirubber Industries (Kedah) Sdn. Bhd.

    K Number Device Name
    K984309 NBR 4 MILS, NITRILE EXAMINATION GLOVE NON-STERILE POWDERED
    K984311 NBR4 MILS NITRILE POWDER FREE EXAMINATION GLOVES NON-STERILE