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510(k) Data Aggregation

    K Number
    K050913
    Device Name
    DICK'S FORMALWEAR MALE LATEX CONDOM
    Date Cleared
    2006-04-04

    (357 days)

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

    DICK'S FORMALWEAR INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Dick's Formalwear® Male Latex Condoms is to be used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases, including human immunodeficiency virus (HIV)).
    Device Description
    These condoms are made of a high quality natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. These three types of condoms (plain, ribbed, and dotted), have a nominal length of 180 mm, nominal width of 54 mm, and a nominal thickness of 0.05 mm. They are all lubricated with a silicone lubricant and have a reservoir tip for extra safety. The condoms are also printed on the exterior of the latex with a graphic design per section 11.1 of ISO 4074:2002 and have passed toxicity and biocompatibility testing.
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