The following data is part of a premarket notification filed by Pleasure Latex Products Sdn. Bhd. with the FDA for Spermicidal Lubricated Male Latex Condom.
| Device ID | K001377 |
| 510k Number | K001377 |
| Device Name: | SPERMICIDAL LUBRICATED MALE LATEX CONDOM |
| Classification | Condom With Nonoxynol-9 |
| Applicant | PLEASURE LATEX PRODUCTS SDN. BHD. LOT 1365, 17TH MILES, JALAN SUNGAI SEMBILANG Jeram, Selangor, MY 45800 |
| Contact | Lim Koi-yong |
| Correspondent | Lim Koi-yong PLEASURE LATEX PRODUCTS SDN. BHD. LOT 1365, 17TH MILES, JALAN SUNGAI SEMBILANG Jeram, Selangor, MY 45800 |
| Product Code | LTZ |
| CFR Regulation Number | 884.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-01 |
| Decision Date | 2000-06-08 |