FDA Product Code
FDA Product Code LTZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.5310
510(k) Clearances — 22 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K033163 | CAUTION CONDOMS | Richard Van Haussen America, Inc. | 2004-04-27 | Traditional | PDF ↗ |
| K012969 | DOUBLE SPRINGERS NONOXNOL 9 CONDOM | Medtech Products , Ltd. | 2002-06-12 | Abbreviated | PDF ↗ |
| K010178 | SPERMICIDAL LUBRICATED MALE LATEX CONDOM | Innolatex Sdn. Bhd | 2001-04-27 | Abbreviated | PDF ↗ |
| K003375 | CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX | Tecnilatex S.A. | 2001-01-28 | Abbreviated | PDF ↗ |
| K001978 | 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9 | Thai Nippon Rubber Industry Co., Ltd. | 2000-08-08 | Abbreviated | PDF ↗ |
| K001377 | SPERMICIDAL LUBRICATED MALE LATEX CONDOM | Pleasure Latex Products Sdn. Bhd. | 2000-06-08 | Abbreviated | PDF ↗ |
| K992438 | INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT) | Indus Medicare , Ltd. | 1999-08-02 | Abbreviated | PDF ↗ |
| K991047 | HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE) | Hardcover Products, Inc. | 1999-06-18 | Abbreviated | PDF ↗ |
| K990669 | MULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9) | Dongkuk Techco Rubber Industries Sdn. Bhd. | 1999-05-17 | Abbreviated | PDF ↗ |
| K981955 | MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS | Ls Rubber Sdn Bhd | 1999-03-15 | Traditional | PDF ↗ |
| K981621 | ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS | Suretex Prophylactics (India) , Ltd. | 1998-06-19 | Traditional | PDF ↗ |
| K974324 | LATEX CONDOMS COLOUR WITH SPERMICIDAL LUBRICANT | Reddy Medtech Health Products , Ltd. | 1998-02-09 | Traditional | PDF ↗ |
| K974326 | LATEX CONDOMS (NATURAL COLOUR) | Reddy Medtech Health Products , Ltd. | 1998-02-09 | Traditional | PDF ↗ |
| K972836 | ROYALE BRAND LATEX CONDOMS-SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS | G. Premjee (Usa), Inc. | 1997-10-22 | Traditional | PDF ↗ |
| K972430 | EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9 | Custom Services Intl., Inc. | 1997-09-10 | Traditional | PDF ↗ |
| K972429 | INNERWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9 | Custom Services Intl., Inc. | 1997-09-10 | Traditional | PDF ↗ |
| K970791 | INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHTY | Custom Services Intl., Inc. | 1997-06-03 | Traditional | PDF ↗ |
| K963322 | OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN | Custom Services Intl., Inc. | 1997-01-22 | Traditional | PDF ↗ |
| K953813 | LONDON ROYAL CONSUMER PRODUCTS LATEX CONDOMS | London International U.S. Holdings, Inc. | 1996-07-22 | Traditional | PDF ↗ |
| K952415 | DUREX, RAMSES, SHEIK | London International U.S. Holdings, Inc. | 1996-07-15 | Traditional | PDF ↗ |
| K931220 | SPERMICIDAL LUBRICATED CONDOM | Monsys USA, Inc. | 1996-05-22 | Traditional | PDF ↗ |
| K904273 | MAGNUM PLUS LATEX CONDOMS WITH SPERMICIDAL LUB. | Carter Products | 1990-10-31 | Traditional | PDF ↗ |
Product code LTZ · Class II · Obstetrics/Gynecology. Data: openFDA.