The following data is part of a premarket notification filed by Pleasure Latex Products Sdn. Bhd. with the FDA for Multiple, Male Latex Condom [52mm Or 56mm Nominal Width With Smooth Or Dotted Or Ribbed Or 3 In 1 (dotted/ribbed/contour.
| Device ID | K023333 |
| 510k Number | K023333 |
| Device Name: | MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOUR |
| 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 | Yes |
| Date Received | 2002-10-07 |
| Decision Date | 2003-06-23 |