'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9
Device Facts
| Record ID | K001978 |
|---|---|
| Device Name | 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9 |
| Applicant | Thai Nippon Rubber Industry Co., Ltd. |
| Product Code | LTZ · Obstetrics/Gynecology |
| Decision Date | Aug 8, 2000 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 884.5310 |
| Device Class | Class 2 |
Regulatory Classification
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).
