SPERMICIDAL LUBRICATED MALE LATEX CONDOM
Device Facts
| Record ID | K010178 |
|---|---|
| Device Name | SPERMICIDAL LUBRICATED MALE LATEX CONDOM |
| Applicant | Innolatex Sdn. Bhd |
| Product Code | LTZ · Obstetrics/Gynecology |
| Decision Date | Apr 27, 2001 |
| 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).
