Latex Condoms W/Spermicidal Lubricant (Nonoxynol-9)
510(k) K942858
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK942858 | Date18 May 1995 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
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- Withdrawn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
This device is a condom, a barrier contraceptive designed to prevent pregnancy and sexually transmitted infections by covering the penis during sexual intercourse. The latex sheath is lubricated with a spermicidal agent, Nonoxynol-9, which provides additional contraceptive protection by immobilizing and killing sperm. Condoms are classified as Class II medical devices under FDA regulations, requiring premarket notification (510(k)) for market clearance. Their primary function is to act as a physical barrier to block semen and reduce exposure to infectious agents during intercourse.
Latex condoms with spermicidal lubricant are supplied as single-use, non-sterile products intended for over-the-counter distribution. They are not intended for reuse or medical procedures but rather for personal contraceptive use. The device is regulated under FDA’s 510(k) clearance (K942858) and falls under the Obstetrics/Gynecology advisory committee classification. Storage instructions are not specified in the data, but typical recommendations include keeping condoms in a cool, dry place away from direct sunlight or extreme temperatures. The device is not MRI-safe or intended for medical imaging.
Other devices from Suretex, Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the primary purpose of these latex condoms with spermicidal lubricant?
These condoms are designed as a barrier contraceptive to prevent pregnancy and reduce the risk of sexually transmitted infections (STIs) during sexual intercourse. The latex sheath physically blocks semen, while the Nonoxynol-9 lubricant provides additional contraceptive protection by immobilizing and killing sperm.
Are these condoms intended for reuse or medical procedures?
No, these condoms are strictly for single-use personal contraception and are not intended for reuse or medical procedures. They are classified as over-the-counter products and should only be used once per act of intercourse.
Are these condoms sterile?
No, these latex condoms with spermicidal lubricant are supplied as non-sterile products. Sterility is not required for this type of personal contraceptive device, as it is intended for consumer use rather than clinical or surgical applications.
How should these condoms be stored?
While specific storage instructions are not detailed in the data, typical recommendations for latex condoms include keeping them in a cool, dry place away from direct sunlight or extreme temperatures. Avoid storing them in hot or humid environments, such as a glove compartment or bathroom, to prevent degradation.
What regulatory pathway does this device follow?
This device follows the FDA’s 510(k) premarket notification pathway, classified as a Class II medical device under the Obstetrics/Gynecology category. It was granted substantial equivalence (SESE) under clearance number K942858, meaning it is deemed to have the same intended use and technological characteristics as a legally marketed predicate device.