đź“‹ FDA Reference
male latex comdom with dotted surface
Pleasure Latex Products Sdn. Bhd.
Summary: The male latex condom with a dotted surface is a contraceptive device designed to enhance sexual pleasure while providing protection against sexually transmitted infections (STIs) and unintended pregnancies. It is commonly used by sexually active individuals.
FDA Clearance Information
Pathway
510K
Number
K001221 ↗
Decision Date
May 19, 2000
Product Code
HIS
Device Class
Class 2
Evidence
0 studies
This male latex condom with a dotted surface was cleared through the FDA 510(k) pathway on May 19, 2000. Manufactured by Pleasure Latex Products Sdn. Bhd., it is classified as a Class 2 medical device.
What It Is
This device is a male latex condom featuring a dotted surface designed to increase tactile stimulation during intercourse. Made from natural latex, it acts as a barrier to prevent the exchange of bodily fluids, thereby reducing the risk of STIs and unintended pregnancies. The dotted texture aims to enhance pleasure for both partners.
Clinical Applications
The male latex condom with a dotted surface is primarily used in sexual health settings, including family planning clinics and sexual health education programs. It is suitable for sexually active individuals seeking both contraception and STI prevention. The device is also used in counseling sessions to promote safe sex practices.
Indications for Use
The FDA-cleared indications for this device include its use as a barrier method for contraception and as a protective measure against sexually transmitted infections. It is intended for use by males during sexual intercourse.
Practical Considerations
These condoms are available in various sizes to accommodate different anatomical needs. They are compatible with water-based lubricants, which can enhance comfort and effectiveness. Proper technique in application is essential to ensure maximum protection and pleasure.
Frequently Asked Questions
What is the male latex condom with dotted surface used for?
It is used for contraception and to reduce the risk of sexually transmitted infections while enhancing sexual pleasure.
What specialties typically use this device?
This device is commonly used in sexual health, family planning, and general practice settings.
What are the FDA-cleared indications?
The device is indicated for use as a contraceptive barrier and to prevent sexually transmitted infections during intercourse.
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.