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

    UniTex Non-Sterile, Powder-Free, Latex Examination Glove

    K Number: K161961 · Decision May 11, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    5
    Review Days
    297

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    Basic Information

    Device Name
    UniTex Non-Sterile, Powder-Free, Latex Examination Glove
    K Number
    K161961
    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
    July 18, 2016
    Decision Date
    May 11, 2017
    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
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    K111604 LANO-E