BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇭 Thailand

    Onetouch Non-paraben Lubricant Gel

    K Number: K220273 · Decision Oct 21, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    242
    Applicant Total
    5
    Review Days
    263

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    Basic Information

    Device Name
    Onetouch Non-paraben Lubricant Gel
    K Number
    K220273
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Thai Nippon Rubber Industry Public Company Limited.
    Date Received
    January 31, 2022
    Decision Date
    October 21, 2022
    Product Code
    NUC
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NUC Lubricant, Personal

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    Other Clearances by Thai Nippon Rubber Industry Public Company Limited.

    K Number Device Name
    K210095 Playboy Premium Silicone Lubricant
    K211450 Playboy 3 Contour Condom
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    K171213 One Touch Condom with Benzocaine