The following data is part of a premarket notification filed by Karex Industries Sdn Bhd with the FDA for Black Coloured Condom.
| Device ID | K132597 |
| 510k Number | K132597 |
| Device Name: | BLACK COLOURED CONDOM |
| Classification | Condom |
| Applicant | KAREX INDUSTRIES SDN BHD PTD. 7906/7907, TAMAN PONTIAN JAYA, BT. 34, JALAN JOHOR Pontian, Johor, MY 82000 |
| Contact | Mary Goh Yin |
| Correspondent | Mary Goh Yin KAREX INDUSTRIES SDN BHD PTD. 7906/7907, TAMAN PONTIAN JAYA, BT. 34, JALAN JOHOR Pontian, Johor, MY 82000 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-19 |
| Decision Date | 2013-11-25 |