Latex Condom
510(k) K941258
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK941258 | Date6 Dec 1995 | StatusActive |
Recalls
-
- Terminated Z-0717-2013
One lot of Lifestyles Pleasure Collection Lubricated Condoms is misbranded. Ultra Thin was included rather than Skyn.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HIS
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.5300
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Latex Condom is a barrier contraceptive device classified as a condom (21 CFR 884.5300), designed to prevent pregnancy and sexually transmitted infections by covering the penis during sexual intercourse. Fabricated from synthetic rubber polyisoprene latex, it features a fitted sheath with an integral ring at the open end and a reservoir tip at the closed end, providing both protection and ease of use. The device is intended for single-use applications in obstetrics and gynecology settings.
Supplied as a sterile, single-use product, the Latex Condom is intended for use in human sexual health contexts. It is classified as a Class II medical device under FDA regulations (21 CFR 884.5300) and holds a 510(k) clearance (K941258) for substantial equivalence. Storage conditions are not specified in the data, but typical latex condoms require protection from extreme temperatures and direct sunlight. The device is not intended for reuse or medical procedures beyond its contraceptive purpose.
Other devices from Suretex, Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the Suretex Latex Condom designed for?
The Suretex Latex Condom is a barrier contraceptive device intended to prevent pregnancy and sexually transmitted infections (STIs) by covering the penis during sexual intercourse. It is specifically designed for use in human sexual health contexts, providing both contraceptive and protective benefits during intercourse.
How is the Suretex Latex Condom supplied and what does this mean for its use?
The Suretex Latex Condom is supplied as a sterile, single-use product. This means each condom is individually packaged to maintain sterility and is intended for one-time use only. Using it more than once could compromise its protective properties and increase the risk of failure.
Is the Suretex Latex Condom made from natural rubber latex?
No, the Suretex Latex Condom is fabricated from synthetic rubber polyisoprene latex, not natural rubber latex. This synthetic material is designed to provide similar protective benefits while potentially reducing the risk of allergic reactions that some individuals may experience with natural latex.
What features does the Suretex Latex Condom include for ease of use?
The condom features a fitted sheath with an integral ring at the open end, which helps secure it in place during use, and a reservoir tip at the closed end. These design elements enhance comfort and ease of application, ensuring better protection and a more reliable contraceptive experience.
What storage conditions should be considered for the Suretex Latex Condom?
While specific storage conditions are not detailed in the data, latex condoms generally require protection from extreme temperatures and direct sunlight. Storing them in a cool, dry place away from heat sources and sunlight helps maintain their integrity and effectiveness.