đź“‹ FDA Reference
male latex condom with dotted ribbed surface and counour-walled shape 3 in 1 ultimate male latex condom
Pleasure Latex Products Sdn. Bhd.
Summary: The 3 in 1 Ultimate Male Latex Condom is a contraceptive device designed for sexual health protection. It is used primarily by sexually active males to prevent pregnancy and reduce the risk of sexually transmitted infections (STIs).
FDA Clearance Information
Pathway
510K
Number
K021875 ↗
Decision Date
September 5, 2002
Product Code
HIS
Device Class
Class 2
Evidence
0 studies
The 3 in 1 Ultimate Male Latex Condom by Pleasure Latex Products was cleared through the FDA 510(k) pathway on September 5, 2002. It is classified as a Class 2 medical device.
What It Is
This device is a male latex condom featuring a dotted and ribbed surface with a contour-walled shape, designed to enhance pleasure while providing effective contraception and STI prevention. The latex material acts as a barrier to prevent sperm from entering the female reproductive tract and reduces the transmission of infectious agents.
Clinical Applications
Male latex condoms are commonly used in sexual health clinics, family planning settings, and by individuals in the general population. They are essential in preventing unintended pregnancies and protecting against STIs, including HIV. Condoms are recommended for use in any sexual encounter where there is a risk of STI transmission or unwanted pregnancy.
Indications for Use
The FDA indications for this condom include its use as a contraceptive device and a barrier to reduce the risk of STIs. It is intended for sexually active males who wish to prevent pregnancy and protect themselves and their partners from infections.
Practical Considerations
The 3 in 1 Ultimate Male Latex Condom is available in standard sizes and is compatible with water-based lubricants. Users should ensure proper fit and application technique to maximize effectiveness. It is important to check for any latex allergies before use.
Frequently Asked Questions
What is the 3 in 1 Ultimate Male Latex Condom used for?
It is used for contraception and reducing the risk of sexually transmitted infections.
What specialties typically use this device?
Specialties such as sexual health, family planning, and general practice commonly recommend this device.
What are the FDA-cleared indications?
The condom is indicated for contraception and as a barrier to reduce the risk of sexually transmitted infections.
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.