FDA 510(k) Applications for Medical Device Product Code "LTZ"
(Condom With Nonoxynol-9)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K972430 | CUSTOM SERVICES INTL., INC. | EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9 | 09/10/1997 |
| K972429 | CUSTOM SERVICES INTL., INC. | INNERWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9 | 09/10/1997 |
| K970791 | CUSTOM SERVICES INTL., INC. | INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHTY | 06/03/1997 |
| K963322 | CUSTOM SERVICES INTL., INC. | OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN | 01/22/1997 |
| K990669 | DONGKUK TECHCO RUBBER INDUSTRIES SDN. BHD. | MULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9) | 05/17/1999 |
| K972836 | G. PREMJEE (USA), INC. | ROYALE BRAND LATEX CONDOMS-SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS | 10/22/1997 |
| K991047 | HARDCOVER PRODUCTS, INC. | HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE) | 06/18/1999 |
| K992438 | INDUS MEDICARE LTD. | INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT) | 08/02/1999 |
| K010178 | INNOLATEX SDN. BHD | SPERMICIDAL LUBRICATED MALE LATEX CONDOM | 04/27/2001 |
| K952415 | LONDON INTERNATIONAL U.S. HOLDINGS, INC. | DUREX, RAMSES, SHEIK | 07/15/1996 |
| K953813 | LONDON INTERNATIONAL U.S. HOLDINGS, INC. | LONDON ROYAL CONSUMER PRODUCTS LATEX CONDOMS | 07/22/1996 |
| K981955 | LS RUBBER SDN BHD | MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS | 03/15/1999 |
| K012969 | MEDTECH PRODUCTS LTD. | DOUBLE SPRINGERS NONOXNOL 9 CONDOM | 06/12/2002 |
| K931220 | MONSYS USA, INC. | SPERMICIDAL LUBRICATED CONDOM | 05/22/1996 |
| K001377 | PLEASURE LATEX PRODUCTS SDN. BHD. | SPERMICIDAL LUBRICATED MALE LATEX CONDOM | 06/08/2000 |
| K974326 | REDDY MEDTECH HEALTH PRODUCTS LTD. | LATEX CONDOMS (NATURAL COLOUR) | 02/09/1998 |
| K974324 | REDDY MEDTECH HEALTH PRODUCTS LTD. | LATEX CONDOMS COLOUR WITH SPERMICIDAL LUBRICANT | 02/09/1998 |
| K033163 | RICHARD VAN HAUSSEN AMERICA, INC. | CAUTION CONDOMS | 04/27/2004 |
| K981621 | SURETEX PROPHYLACTICS (INDIA) LTD. | ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS | 06/19/1998 |
| K003375 | TECNILATEX S.A. | CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX | 01/28/2001 |
| K001978 | THAI NIPPON RUBBER INDUSTRY CO., LTD. | 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9 | 08/08/2000 |
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