The following data is part of a premarket notification filed by Pleasure Latex Products Sdn. Bhd. with the FDA for Male Latex Comdom With Dotted Surface.
| Device ID | K001221 |
| 510k Number | K001221 |
| Device Name: | MALE LATEX COMDOM WITH DOTTED SURFACE |
| Classification | Condom |
| Applicant | PLEASURE LATEX PRODUCTS SDN. BHD. LOT 1365, 17TH MILES, JALAN SUNGAI SEMBILANG Jeram, Selangor, MY 45800 |
| Contact | Koi-yong Lim |
| Correspondent | Koi-yong Lim PLEASURE LATEX PRODUCTS SDN. BHD. LOT 1365, 17TH MILES, JALAN SUNGAI SEMBILANG Jeram, Selangor, MY 45800 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-17 |
| Decision Date | 2000-05-19 |