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510(k) Data Aggregation
K Number
K050913Device Name
DICK'S FORMALWEAR MALE LATEX CONDOM
Manufacturer
Date Cleared
2006-04-04
(357 days)
Product Code
Regulation Number
884.5300Why 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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