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

    'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9

    K Number: K001978 · Decision Aug 8, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    21
    Applicant Total
    6
    Review Days
    40

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    Basic Information

    Device Name
    'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9
    K Number
    K001978
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    884.5310
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Thai Nippon Rubber Industry Co., Ltd.
    Date Received
    June 29, 2000
    Decision Date
    August 8, 2000
    Product Code
    LTZ
    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
    LTZ Condom With Nonoxynol-9

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LTZ), ordered by most recent decision date.

    CAUTION CONDOMS

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    SPERMICIDAL LUBRICATED MALE LATEX CONDOM

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    SPERMICIDAL LUBRICATED MALE LATEX CONDOM

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    INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
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