← Product Code [HIS](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HIS) · K963679

# LOVING SMARTER - SAFER SEX (K963679)

_Loving Smarter, Inc. · HIS · Dec 12, 1996 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HIS/K963679

## Device Facts

- **Applicant:** Loving Smarter, Inc.
- **Product Code:** [HIS](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HIS.md)
- **Decision Date:** Dec 12, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.5300
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## 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.

## Regulatory 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.

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

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K963679

DEC 12 1996

ENCLOSURE C

Summary of Information on Safety and Effectiveness

The medical devices and drugs contained in The Loving Smarter- Safer Sex Kit are:

1. Latex Male Condoms

2. Personal Lubricants, Water-based

A research of medical journals supports a finding that these products are safe and effective. Some individuals may have allergic reaction to some of the products.

All medical devices and drugs contained in the Loving Smarter- Safer Sex Kit will be purchased from manufacturers and distributors. The products will be substantially equivalent to products that are legally marketed in the United States.

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HIS/K963679](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HIS/K963679)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com