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510(k) Data Aggregation
K Number
K060797Device Name
NAKED
Manufacturer
Date Cleared
2006-04-07
(14 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
VERAXIS INT'L INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Veraxis Int'l Inc. Naked™ condom is to be used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Device Description
By creating an actual physical barrier between partners engaged in sexual activity, the condom represents the best available solution to two of the world's major health challenges: sexually transmitted diseases/AIDS and unwanted pregnancy.
The design of the condom is essential to its effectiveness. The closed end has a reservoir tip to contain semen. The condom described herein has an integral ring at its base and a snug fit along its lower portion in order to ensure a safe, secure seal and barrier.
The design of the Naked™ condom described herein addresses these deficiencies so that condom usage will significantly improve among sexually active populations. The condom described herein provides a slightly relaxed fit along the main body of the product between the snug base and reservoir tip. This relaxed fit provides a more natural feel during intercourse, an easier application process, and improved sensation, while maintaining a safe, secure seal and barrier.
This product is designed to fully conform to ISO 10993 and ISO 4074. It also conforms to ASTM D3492.
This condom has the same technical characteristics as the predicate condoms identified above. The product described herein features a slightly relaxed fit along the main body of the product. The relaxed fit at the closed end of the condom provides a greater lay flat width than the width of the snug base and safety seal it creates at the open end of the condom.
The Naked ™ condom comes in a range of sizes that provide increased customization for each individual which makes for a safer, more secure, and better fit. These two technical characteristics (relaxed fit and various sizes) maximize product effectiveness and sensation, and thereby increase product usage among the sexually active populations.
As stated in the product description, this product is designed to fully conform to ISO 10993 and ISO 4074. It also conforms to ASTM D3492.
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