Condom With Nonoxynol-9
FDA product code LTZ · Class II (moderate risk) · 21 CFR 884.5310 · Obstetrics/Gynecology
22510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Custom Services Intl., Inc. 4
- London International U.S. Holdings, Inc. 2
- Reddy Medtech Health Products , Ltd. 2
- Dongkuk Techco Rubber Industries Sdn. Bhd. 1
- Richard Van Haussen America, Inc. 1
- Medtech Products, Inc. 1
- Innolatex Sdn. Bhd 1
- Tecnilatex S.A. 1
- Thai Nippon Rubber Industry Co., Ltd. 1
- Pleasure Latex Products Sdn. Bhd. 1
- Indus Medicare , Ltd. 1
- Hardcover Products, Inc. 1
- Carter Products 1
- Ls Rubber Sdn Bhd 1
- Suretex Prophylactics (India) , Ltd. 1
- G. Premjee (Usa), Inc. 1
- Monsys USA, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K033163 | Caution CondomsLTZ · Traditional | Richard Van Haussen America, Inc. | 04/27/2004SE |
| K012969 | Double Springers Nonoxnol 9 CondomLTZ · Abbreviated | Medtech Products , Ltd. | 06/12/2002SE |
| K010178 | Spermicidal Lubricated Male Latex CondomLTZ · Abbreviated | Innolatex Sdn. Bhd | 04/27/2001SE |
| K003375 | Control Male Condoms of Natural Rubber LatexLTZ · Abbreviated | Tecnilatex S.A. | 01/28/2001SE |
| K001978 | 'One Touch' Latex Condom with NONOXYNOL-9LTZ · Abbreviated | Thai Nippon Rubber Industry Co., Ltd. | 08/08/2000SE |
| K001377 | Spermicidal Lubricated Male Latex CondomLTZ · Abbreviated | Pleasure Latex Products Sdn. Bhd. | 06/08/2000SE |
| K992438 | Invigra Plus (with Spermicidal Lubricant)LTZ · Abbreviated | Indus Medicare , Ltd. | 08/02/1999SE |
| K991047 | Hardcover Condoms Male Latex Condoms, (with Spermicide)LTZ · Abbreviated | Hardcover Products, Inc. | 06/18/1999SE |
| K990669 | Multiple-Brand Male Latex Condom (Lubricated with NONOXYNOL-9)LTZ · Abbreviated | Dongkuk Techco Rubber Industries Sdn. Bhd. | 05/17/1999SE |
| K981955 | Maxima, Trustex, Ria and Premium El Les CondomsLTZ · Traditional | Ls Rubber Sdn Bhd | 03/15/1999SE |
| K981621 | Royale of Latex Condoms - Spermicidal Lubricant - Colored or Assorted ColorsLTZ · Traditional | Suretex Prophylactics (India) , Ltd. | 06/19/1998SE |
| K974326 | Latex Condoms (Natural Colour)LTZ · Traditional | Reddy Medtech Health Products , Ltd. | 02/09/1998SE |
| K974324 | Latex Condoms Colour with Spermicidal LubricantLTZ · Traditional | Reddy Medtech Health Products , Ltd. | 02/09/1998SE |
| K972836 | Royale Brand Latex Condoms-Spermicidal Lubricant - Colored or Assorted ColorsLTZ · Traditional | G. Premjee (Usa), Inc. | 10/22/1997SE |
| K972430 | Extrawear, Gentlemen's Choice W/NONOXYNOL-9LTZ · Traditional | Custom Services Intl., Inc. | 09/10/1997SE |
| K972429 | Innerwear, Gentlemen's Choice W/NONOXYNOL-9LTZ · Traditional | Custom Services Intl., Inc. | 09/10/1997SE |
| K970791 | Innerwear/Extrawear/Jimmy-O Raincoat/Zeus/Gentlemen's Choice/Jasmine/Drink/NaughtyLTZ · Traditional | Custom Services Intl., Inc. | 06/03/1997SE |
| K963322 | Olympus,Jasmine,Jimmy-O Raincoat,Drink,Ares,Aphrodite,Zeus,Apollo,Selfcare,Careplus,TitanLTZ · Traditional | Custom Services Intl., Inc. | 01/22/1997SE |
| K953813 | London Royal Consumer Products Latex CondomsLTZ · Traditional | London International U.S. Holdings, Inc. | 07/22/1996SE |
| K952415 | Durex, Ramses, SheikLTZ · Traditional | London International U.S. Holdings, Inc. | 07/15/1996SE |
| K931220 | Spermicidal Lubricated CondomLTZ · Traditional | Monsys USA, Inc. | 05/22/1996SE |
| K904273 | Magnum Plus Latex Condoms with Spermicidal Lub.LTZ · Traditional | Carter Products | 10/31/1990SE |