Condom With Nonoxynol-9
Condom with Nonoxynol-9 (product code LTZ) is a male barrier contraceptive device made of latex or similar material coated with nonoxynol-9, a spermicidal agent intended to provide both contraceptive protection and additional prophylactic activity against sexually transmitted infections. Regulated under 21 CFR 884.5310 and classified as a Class 2 device, it requires a 510(k) premarket notification and is eligible for third-party review under the Obstetrics/Gynecology panel. It is not an implant and is not life-sustaining.
Basic Information
- Product Code
- LTZ
- Device Class
- FDA class 2
- Regulation Number
- 884.5310
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 22 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K033163 | CAUTION CONDOMS | Apr 27, 2004 | Substantially Equivalent | RICHARD VAN HAUSSEN AMERICA, INC. |
| K012969 | DOUBLE SPRINGERS NONOXNOL 9 CONDOM | Jun 12, 2002 | Substantially Equivalent | MEDTECH PRODUCTS LTD. |
| K010178 | SPERMICIDAL LUBRICATED MALE LATEX CONDOM | Apr 27, 2001 | Substantially Equivalent | INNOLATEX SDN. BHD |
| K003375 | CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX | Jan 28, 2001 | Substantially Equivalent | TECNILATEX S.A. |
| K001978 | 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9 | Aug 08, 2000 | Substantially Equivalent | THAI NIPPON RUBBER INDUSTRY CO., LTD. |
| K001377 | SPERMICIDAL LUBRICATED MALE LATEX CONDOM | Jun 08, 2000 | Substantially Equivalent | PLEASURE LATEX PRODUCTS SDN. BHD. |
| K992438 | INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT) | Aug 02, 1999 | Substantially Equivalent | INDUS MEDICARE LTD. |
| K991047 | HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE) | Jun 18, 1999 | Substantially Equivalent | HARDCOVER PRODUCTS, INC. |
| K990669 | MULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9) | May 17, 1999 | Substantially Equivalent | DONGKUK TECHCO RUBBER INDUSTRIES SDN. BHD. |
| K981955 | MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS | Mar 15, 1999 | Substantially Equivalent | LS RUBBER SDN BHD |
| K981621 | ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS | Jun 19, 1998 | Substantially Equivalent | SURETEX PROPHYLACTICS (INDIA) LTD. |
| K974326 | LATEX CONDOMS (NATURAL COLOUR) | Feb 09, 1998 | Substantially Equivalent | REDDY MEDTECH HEALTH PRODUCTS LTD. |
| K974324 | LATEX CONDOMS COLOUR WITH SPERMICIDAL LUBRICANT | Feb 09, 1998 | Substantially Equivalent | REDDY MEDTECH HEALTH PRODUCTS LTD. |
| K972836 | ROYALE BRAND LATEX CONDOMS-SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS | Oct 22, 1997 | Substantially Equivalent | G. PREMJEE (USA), INC. |
| K972430 | EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9 | Sep 10, 1997 | Substantially Equivalent | CUSTOM SERVICES INTL., INC. |
| K972429 | INNERWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9 | Sep 10, 1997 | Substantially Equivalent | CUSTOM SERVICES INTL., INC. |
| K970791 | INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHTY | Jun 03, 1997 | Substantially Equivalent | CUSTOM SERVICES INTL., INC. |
| K963322 | OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN | Jan 22, 1997 | Substantially Equivalent | CUSTOM SERVICES INTL., INC. |
| K953813 | LONDON ROYAL CONSUMER PRODUCTS LATEX CONDOMS | Jul 22, 1996 | Substantially Equivalent | LONDON INTERNATIONAL U.S. HOLDINGS, INC. |
| K952415 | DUREX, RAMSES, SHEIK | Jul 15, 1996 | Substantially Equivalent | LONDON INTERNATIONAL U.S. HOLDINGS, INC. |
| K931220 | SPERMICIDAL LUBRICATED CONDOM | May 22, 1996 | Substantially Equivalent | MONSYS USA, INC. |
| K904273 | MAGNUM PLUS LATEX CONDOMS WITH SPERMICIDAL LUB. | Oct 31, 1990 | Substantially Equivalent | CARTER PRODUCTS |
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.