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

    NATURAL RUBBER LATEX MALE CONDOMS

    K Number: K141059 · Decision Aug 1, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    400
    Applicant Total
    8
    Review Days
    99

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    Basic Information

    Device Name
    NATURAL RUBBER LATEX MALE CONDOMS
    K Number
    K141059
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Karex Industries Sdn. Bhd.
    Date Received
    April 24, 2014
    Decision Date
    August 1, 2014
    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 Karex Industries Sdn. Bhd.

    K Number Device Name
    K223519 Carex Hybrid Personal Lubricant
    K150743 Water Based Personal Lubricant with Flavours
    K132597 BLACK COLOURED CONDOM
    K113056 ORANGE COLORED CONDOMS ORANGE SCENT
    K113061 LARGE/EXTRA LAGRE CONDOM
    K081886 KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED
    K070830 MALE NATURAL RUBBER LATEX CONDOM (WITH COLORING AND FLAVORING)