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510(k) Data Aggregation

    K Number
    K052206
    Device Name
    ZEUS MALE CONDOM APPLICATOR
    Manufacturer
    CONDAX LLC.
    Date Cleared
    2006-09-12

    (396 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONDAX LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Zeus™ Male Condom Applicator facilitates correct positioning (donning) of a male latex condom prior to sexual intercoursc. The condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
    Device Description
    The Zeus™ Male Condom Applicator is a bell shaped pouch that is open at one end and closed at the other. It is molded from polyethylene plastic. The applicator is designed to hold a latex condom in place for correct donning onto an erect penis. All surfaces and edges of the applicator are rounded to prevent damage to condom. Silicone or water-based lubricant is added to the condom prior to packaging. Approximately 2.5 inches of the condom is unrolled and lies nestled, but not firmly held, within the walls of the applicator. The width of the applicator at the point where the condom is attached is 54mm thus enabling a 52mm (nominal width) condom to be held prior to use without imparting a permanent stretch to the condom. The applicator and condom are packaged and sealed in an aluminum foil wrapper. The applicator and attached condom are removed together from the package prior to use. The user cups the device in either hand and then, during the application process, squeezes the edges of the applicator which forces the sides to bellow-out, and thus opens the attached condom The device is centered over the head of the penis and is lowered to a point that the penis makes contact with the interior condom wall. The user then uses his thumb to unroll the condom from the applicator and onto the penis. The user continues to unroll the bead as far down the penis as possible. The applicator is removed from the penis and discarded (prior to intercourse).
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    K Number
    K031007
    Device Name
    KWIKEZE MALE CONDOM APPLICATOR
    Manufacturer
    CONDAX LLC.
    Date Cleared
    2003-11-14

    (228 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONDAX LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kwikeze Male Condom Applicator facilitates correct positioning (donning) of a male latex condom prior to sexual intercourse. The condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)
    Device Description
    The Kwikeze™ Male Condom Applicator is an elliptical ring made of polyethylene plastic. When packaged, the applicator is collapsed on self-scored lines in a manner that allows the condom to be loosely positioned within the inner-folds of the ring. The collapsed applicator is held in position with a polyurethane band. The condom is stretched slightly to position it on top of the applicator. This configuration allows the condom to rest un-stretched until time of use. After opening the sealed foil package, and prior to use, the band is removed allowing the ring and condom to expand to its original oval shape. The device when pulled opened expands the attached condom enough to allow for easy insertion and correct positioning of the condom on the erect penis.
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