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

    LANO-E

    K Number: K111604 · Decision Jun 8, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    5
    Review Days
    366

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    Basic Information

    Device Name
    LANO-E
    K Number
    K111604
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ug Global Resources Sdn. Bhd.
    Date Received
    June 8, 2011
    Decision Date
    June 8, 2012
    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 Ug Global Resources Sdn. Bhd.

    K Number Device Name
    K232319 Black Pearl Nitrile Examination Glove
    K162510 Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue
    K161961 UniTex Non-Sterile, Powder-Free, Latex Examination Glove
    K111718 LANO-E