BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇲🇾 Malaysia

    MULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9)

    K Number: K990669 · Decision May 17, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    21
    Applicant Total
    1
    Review Days
    76

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    Basic Information

    Device Name
    MULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9)
    K Number
    K990669
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    884.5310
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dongkuk Techco Rubber Industries Sdn. Bhd.
    Date Received
    March 2, 1999
    Decision Date
    May 17, 1999
    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

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

    DOUBLE SPRINGERS NONOXNOL 9 CONDOM

    FDA 510(k)
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    SPERMICIDAL LUBRICATED MALE LATEX CONDOM

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

    CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX

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

    'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9

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

    SPERMICIDAL LUBRICATED MALE LATEX CONDOM

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