← Product Code [LTZ](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/LTZ) · K003375

# CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX (K003375)

_Tecnilatex S.A. · LTZ · Jan 28, 2001 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/LTZ/K003375

## Device Facts

- **Applicant:** Tecnilatex S.A.
- **Product Code:** [LTZ](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/LTZ.md)
- **Decision Date:** Jan 28, 2001
- **Decision:** SESE
- **Submission Type:** Abbreviated
- **Regulation:** 21 CFR 884.5310
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Regulatory Identification

A condom with spermicidal lubricant is a sheath which completely covers the penis with a closely fitting membrane with a lubricant that contains a spermicidal agent, nonoxynol-9. This condom is used for contraceptive and prophylactic purposes (preventing transmission of venereal disease).

---

**Source:** [https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/LTZ/K003375](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/LTZ/K003375)

**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