LOVING SMARTER - SAFER SEX
Device Facts
| Record ID | K963679 |
|---|---|
| Device Name | LOVING SMARTER - SAFER SEX |
| Applicant | Loving Smarter, Inc. |
| Product Code | HIS · Obstetrics/Gynecology |
| Decision Date | Dec 12, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5300 |
| Device Class | Class 2 |
Indications for Use
The medical devices and drugs contained in The Loving Smarter- Safer Sex Kit are: 1. Latex Male Condoms 2. Personal Lubricants, Water-based
Device Story
Kit contains latex male condoms and water-based personal lubricants; sourced from existing manufacturers/distributors; intended for consumer use; provides barrier protection and lubrication; supports safe sex practices.
Clinical Evidence
No clinical data; reliance on literature review of existing marketed products.
Technological Characteristics
Latex male condoms; water-based personal lubricants; standard consumer health products.
Indications for Use
Indicated for individuals seeking barrier protection and lubrication during sexual activity to reduce the risk of pregnancy and sexually transmitted infections.
Regulatory Classification
Identification
A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.
Special Controls
*Classification.* (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.
