BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇹🇭 Thailand

    Comfortpro

    K Number: K212438 · Decision Dec 7, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    2
    Review Days
    125

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    Basic Information

    Device Name
    Comfortpro
    K Number
    K212438
    Device Class
    FDA class 1
    Clearance Type
    Abbreviated
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Thai Rubber Industry Company Limited
    Date Received
    August 4, 2021
    Decision Date
    December 7, 2021
    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 Thai Rubber Industry Company Limited

    K Number Device Name
    K212850 ComfortPro Blue Nitrile Examination Gloves Powder Free