LTZ · Condom With Nonoxynol-9
Obstetrics/Gynecology · 21 CFR 884.5310 · Class 2
Overview
| Product Code | LTZ |
|---|---|
| Device Name | Condom With Nonoxynol-9 |
| Regulation | 21 CFR 884.5310 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 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 | CAUTION CONDOMS | Richard Van Haussen America, Inc. | Apr 27, 2004 | SESE |
| K012969 | DOUBLE SPRINGERS NONOXNOL 9 CONDOM | Medtech Products , Ltd. | Jun 12, 2002 | SESE |
| K010178 | SPERMICIDAL LUBRICATED MALE LATEX CONDOM | Innolatex Sdn. Bhd | Apr 27, 2001 | SESE |
| K003375 | CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX | Tecnilatex S.A. | Jan 28, 2001 | SESE |
| K001978 | 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9 | Thai Nippon Rubber Industry Co., Ltd. | Aug 8, 2000 | SESE |
| K001377 | SPERMICIDAL LUBRICATED MALE LATEX CONDOM | Pleasure Latex Products Sdn. Bhd. | Jun 8, 2000 | SESE |
| K992438 | INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT) | Indus Medicare , Ltd. | Aug 2, 1999 | SESE |
| K991047 | HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE) | Hardcover Products, Inc. | Jun 18, 1999 | SESE |
| K990669 | MULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9) | Dongkuk Techco Rubber Industries Sdn. Bhd. | May 17, 1999 | SESE |
| K981955 | MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS | Ls Rubber Sdn Bhd | Mar 15, 1999 | SESE |
| K981621 | ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS | Suretex Prophylactics (India) , Ltd. | Jun 19, 1998 | SESE |
| K974326 | LATEX CONDOMS (NATURAL COLOUR) | Reddy Medtech Health Products , Ltd. | Feb 9, 1998 | SESE |
| K974324 | LATEX CONDOMS COLOUR WITH SPERMICIDAL LUBRICANT | Reddy Medtech Health Products , Ltd. | Feb 9, 1998 | SESE |
| K972836 | ROYALE BRAND LATEX CONDOMS-SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS | G. Premjee (Usa), Inc. | Oct 22, 1997 | SESE |
| K972430 | EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9 | Custom Services Intl., Inc. | Sep 10, 1997 | SESE |
| K972429 | INNERWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9 | Custom Services Intl., Inc. | Sep 10, 1997 | SESE |
| K970791 | INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHTY | Custom Services Intl., Inc. | Jun 3, 1997 | SESE |
| K963322 | OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN | Custom Services Intl., Inc. | Jan 22, 1997 | SESE |
| K953813 | LONDON ROYAL CONSUMER PRODUCTS LATEX CONDOMS | London International U.S. Holdings, Inc. | Jul 22, 1996 | SESE |
| K952415 | 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
