Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart F — Obstetrical and Gynecological Therapeutic Devices](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices) → [21 CFR 884.5310](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/884.5310) → LTZ — Condom With Nonoxynol-9 # LTZ · Condom With Nonoxynol-9 _Obstetrics/Gynecology · 21 CFR 884.5310 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/LTZ ## Overview - **Product Code:** LTZ - **Device Name:** Condom With Nonoxynol-9 - **Regulation:** [21 CFR 884.5310](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/884.5310) - **Device Class:** 2 - **Review Panel:** [Obstetrics/Gynecology](/submissions/OB) - **3rd-party reviewable:** yes ## 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). ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 22) Showing 20 most recent of 22 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K033163](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/LTZ/K033163.md) | CAUTION CONDOMS | Richard Van Haussen America, Inc. | Apr 27, 2004 | SESE | | [K012969](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/LTZ/K012969.md) | DOUBLE SPRINGERS NONOXNOL 9 CONDOM | Medtech Products , Ltd. | Jun 12, 2002 | SESE | | [K010178](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/LTZ/K010178.md) | SPERMICIDAL LUBRICATED MALE LATEX CONDOM | Innolatex Sdn. Bhd | Apr 27, 2001 | SESE | | [K003375](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/LTZ/K003375.md) | CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX | Tecnilatex S.A. | Jan 28, 2001 | SESE | | [K001978](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/LTZ/K001978.md) | 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9 | Thai Nippon Rubber Industry Co., Ltd. | Aug 8, 2000 | SESE | | [K001377](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/LTZ/K001377.md) | SPERMICIDAL LUBRICATED MALE LATEX CONDOM | Pleasure Latex Products Sdn. Bhd. | Jun 8, 2000 | SESE | | [K992438](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/LTZ/K992438.md) | INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT) | Indus Medicare , Ltd. | Aug 2, 1999 | SESE | | [K991047](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/LTZ/K991047.md) | HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE) | Hardcover Products, Inc. | Jun 18, 1999 | SESE | | [K990669](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/LTZ/K990669.md) | MULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9) | Dongkuk Techco Rubber Industries Sdn. Bhd. | May 17, 1999 | SESE | | [K981955](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/LTZ/K981955.md) | MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS | Ls Rubber Sdn Bhd | Mar 15, 1999 | SESE | | [K981621](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/LTZ/K981621.md) | ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS | Suretex Prophylactics (India) , Ltd. | Jun 19, 1998 | SESE | | [K974326](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/LTZ/K974326.md) | LATEX CONDOMS (NATURAL COLOUR) | Reddy Medtech Health Products , Ltd. | Feb 9, 1998 | SESE | | [K974324](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/LTZ/K974324.md) | LATEX CONDOMS COLOUR WITH SPERMICIDAL LUBRICANT | Reddy Medtech Health Products , Ltd. | Feb 9, 1998 | SESE | | [K972836](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/LTZ/K972836.md) | ROYALE BRAND LATEX CONDOMS-SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS | G. Premjee (Usa), Inc. | Oct 22, 1997 | SESE | | [K972430](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/LTZ/K972430.md) | EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9 | Custom Services Intl., Inc. | Sep 10, 1997 | SESE | | [K972429](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/LTZ/K972429.md) | INNERWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9 | Custom Services Intl., Inc. | Sep 10, 1997 | SESE | | [K970791](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/LTZ/K970791.md) | INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHTY | Custom Services Intl., Inc. | Jun 3, 1997 | SESE | | [K963322](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/LTZ/K963322.md) | OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN | Custom Services Intl., Inc. | Jan 22, 1997 | SESE | | [K953813](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/LTZ/K953813.md) | LONDON ROYAL CONSUMER PRODUCTS LATEX CONDOMS | London International U.S. Holdings, Inc. | Jul 22, 1996 | SESE | | [K952415](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/LTZ/K952415.md) | DUREX, RAMSES, SHEIK | London International U.S. Holdings, Inc. | Jul 15, 1996 | SESE | ## Top Applicants - Custom Services Intl., Inc. — 4 clearances - London International U.S. Holdings, Inc. — 2 clearances - Reddy Medtech Health Products , Ltd. — 2 clearances - Carter Products — 1 clearance - Dongkuk Techco Rubber Industries Sdn. Bhd. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/LTZ](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/LTZ) **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