Loving Smarter Safer Sex Condom
510(k) K963679
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK963679 | Date12 Dec 1996 | 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- Withdrawn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
- Full name
- Loving Smarter - Safer Sex
- 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 latex male condom, classified as a barrier contraceptive designed to prevent pregnancy and reduce the risk of sexually transmitted infections during sexual intercourse. It functions as a physical barrier between partners, blocking sperm and pathogens while maintaining flexibility and durability during use.
The condom is supplied as a single-use, non-sterile product intended for personal use in a non-clinical setting. It is regulated under FDA 510(k) clearance (K963679) as a Class II device, with no MRI safety considerations specified. Available in various sizes and reference codes (e.g., 2084177, 3003592318), it is packaged for individual use and must be stored in a cool, dry place away from direct sunlight.
Questions
AI-generated answers, 1 Oct 2026
What is the Loving Smarter latex condom used for?
The Loving Smarter latex condom is designed as a barrier contraceptive to prevent pregnancy and reduce the risk of sexually transmitted infections (STIs) during sexual intercourse. It works by creating a physical barrier between partners, blocking sperm and pathogens while maintaining flexibility and durability.
How is the condom supplied and intended for use?
This condom is supplied as a single-use, non-sterile product intended exclusively for personal use in non-clinical settings. Each condom is individually packaged for convenience and hygiene.
Is the condom sterile, and can it be reused?
The Loving Smarter latex condom is not sterile—it is explicitly labeled as non-sterile for personal use. It is not designed for reuse and should only be used once to ensure effectiveness and hygiene.
What sizes or reference codes are available for this condom?
The condom is available in multiple sizes and reference codes, including (but not limited to) 2084177 and 3003592318. These variations accommodate different user preferences for fit and comfort. Check the packaging for the specific reference code to confirm sizing.
How should the condom be stored?
Store the condom in a cool, dry place away from direct sunlight to maintain its integrity. Avoid extreme temperatures or moisture, as these can compromise the material’s durability and effectiveness.