The following data is part of a premarket notification filed by Innolatex Sdn. Bhd with the FDA for Spermicidal Lubricated Male Latex Condom.
| Device ID | K010178 |
| 510k Number | K010178 |
| Device Name: | SPERMICIDAL LUBRICATED MALE LATEX CONDOM |
| Classification | Condom With Nonoxynol-9 |
| Applicant | INNOLATEX SDN. BHD NO. 16, JALAN BULAN U5/5, BANDAR PINGGIRAN SUBANG Shah Alam, Selangor D.e., MY 40150 |
| Contact | Chang Au-kau |
| Correspondent | Chang Au-kau INNOLATEX SDN. BHD NO. 16, JALAN BULAN U5/5, BANDAR PINGGIRAN SUBANG Shah Alam, Selangor D.e., MY 40150 |
| Product Code | LTZ |
| CFR Regulation Number | 884.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-19 |
| Decision Date | 2001-04-27 |