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male latex condom with ribbed surface
Pleasure Latex Products Sdn. Bhd.
Summary: The male latex condom with ribbed surface is a barrier device used for contraception and STI prevention. It is primarily used by sexually active individuals seeking enhanced sensation.
FDA Clearance Information
Pathway
510K
Number
K020272 ↗
Decision Date
April 26, 2002
Product Code
HIS
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on April 26, 2002. It is manufactured by Pleasure Latex Products Sdn. Bhd. and is classified as a Class 2 medical device.
What It Is
The male latex condom with ribbed surface is a barrier contraceptive device designed to prevent pregnancy and reduce the transmission of sexually transmitted infections (STIs). The ribbed texture is intended to enhance sensation during intercourse. Made from latex, it is designed to be worn over the penis during sexual activity.
Clinical Applications
This device is commonly used in sexual health clinics, family planning centers, and by individuals at home. It is suitable for sexually active men and their partners who are looking for reliable contraception and STI prevention. The ribbed design may appeal to those seeking additional stimulation.
Indications for Use
The FDA indications for this device include contraception and STI prevention. It is intended for use by sexually active individuals who wish to reduce the risk of pregnancy and sexually transmitted infections.
Practical Considerations
The condom is typically available in various sizes to accommodate different users. It is important to check for latex allergies before use. Proper application technique is crucial for effectiveness, and compatibility with water-based lubricants is recommended.
Related Literature
The study titled 'Promoting condoms in Brazil to men who have sex with men' explored the introduction of a ribbed condom in the Brazilian market. It found that the product was well-received by some men who have sex with men, leading to targeted marketing efforts. However, initial sales were low, indicating potential market challenges.
Frequently Asked Questions
What is the male latex condom with ribbed surface used for?
It is used for contraception and to reduce the risk of sexually transmitted infections.
What specialties typically use this device?
Sexual health and family planning specialists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for contraception and STI prevention.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.