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

    INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED

    K Number: K041837 · Decision Sep 24, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    400
    Applicant Total
    9
    Review Days
    79

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    Basic Information

    Device Name
    INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED
    K Number
    K041837
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Innolatex Sdn. Bhd
    Date Received
    July 7, 2004
    Decision Date
    September 24, 2004
    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 Innolatex Sdn. Bhd

    K Number Device Name
    K053367 MALE NATURAL RUBBER LATEX CONDOM
    K012665 ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT
    K012964 56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM
    K012664 ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT
    K012962 DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM
    K010919 MALE NATURAL RUBBER LATEX CONDOM
    K010178 SPERMICIDAL LUBRICATED MALE LATEX CONDOM
    K002393 NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM