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

    ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT

    K Number: K012665 · Decision Nov 9, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    400
    Applicant Total
    9
    Review Days
    88

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    Basic Information

    Device Name
    ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT
    K Number
    K012665
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Innolatex Sdn. Bhd
    Date Received
    August 13, 2001
    Decision Date
    November 9, 2001
    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
    K041837 INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED
    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