BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    THAI NIPPON MALE LATEX CONDOM

    K Number: K081265 · Decision Oct 16, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    400
    Applicant Total
    6
    Review Days
    529

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    Basic Information

    Device Name
    THAI NIPPON MALE LATEX CONDOM
    K Number
    K081265
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Thai Nippon Rubber Industry Co., Ltd.
    Date Received
    May 5, 2008
    Decision Date
    October 16, 2009
    Product Code
    HIS
    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
    HIS Condom

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    Other Clearances by Thai Nippon Rubber Industry Co., Ltd.

    K Number Device Name
    K142790 OneTouch Lubricant Gel
    K032909 THAI NIPPON EXTRA STRENGTH MALE LATEX CONDOM
    K011253 FLAVORED MALE LATEX CONDOM
    K001978 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9
    K994095 LATEX CONDOM