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latex male condom smooth surface latex male condom textured surface
Medical-Latex (Dua) Sdn. Bhd
Summary: This device is a latex male condom, used primarily for contraception and prevention of sexually transmitted infections. It is used by sexually active males.
FDA Clearance Information
Pathway
510K
Number
K120555 ↗
Decision Date
November 2, 2012
Product Code
HIS
Device Class
Class 2
Evidence
0 studies
This latex male condom was cleared through the FDA 510k pathway on November 2, 2012. It is manufactured by Medical-Latex (Dua) Sdn. Bhd and classified as a Class 2 medical device.
What It Is
The latex male condom is a barrier device made from natural latex designed to cover the penis during sexual intercourse. It works by preventing direct contact and exchange of bodily fluids, thereby reducing the risk of pregnancy and transmission of sexually transmitted infections. The device is available in both smooth and textured surfaces to cater to user preferences.
Clinical Applications
Latex male condoms are commonly used in sexual health clinics, family planning settings, and by individuals seeking reliable contraception. They are also recommended for use in preventing the spread of sexually transmitted infections, including HIV. The device is suitable for use by sexually active males across various age groups.
Indications for Use
The FDA indications for this device include its use as a contraceptive method and as a protective barrier against sexually transmitted infections. It is intended for use by males during sexual intercourse.
Practical Considerations
Latex male condoms are available in various sizes to ensure a proper fit and maximize effectiveness. They should be stored in a cool, dry place to prevent degradation. Users should be aware of potential latex allergies and consider alternatives if necessary.
Related Literature
The linked study investigated the surface characteristics of stretched condom latex, revealing an accordion-like ripple formation and tears. Despite these imperfections, the study found that the condoms did not leak dye, suggesting they still function as effective barriers. However, the presence of tears raises questions about mechanical resistance and quality control, highlighting the importance of rigorous testing.
Frequently Asked Questions
What is a latex male condom used for?
It is used for contraception and to prevent sexually transmitted infections.
What specialties typically use this device?
Specialties include sexual health, family planning, and general practice.
What are the FDA-cleared indications?
The device is indicated for use as a contraceptive and to prevent 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.