The following data is part of a premarket notification filed by Karex Industries Sdn Bhd with the FDA for Natural Rubber Latex Male Condoms.
| Device ID | K141059 |
| 510k Number | K141059 |
| Device Name: | NATURAL RUBBER LATEX MALE CONDOMS |
| Classification | Condom |
| Applicant | KAREX INDUSTRIES SDN BHD PTD. 7906/7907, TAMAN PONTIAN JAYA, BT. 34, JALAN JOHOR Pontian, Johor, MY 82000 |
| Contact | Mary Goh |
| Correspondent | Mary Goh 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 | 2014-04-24 |
| Decision Date | 2014-08-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850002174250 | K141059 | 000 |
| 00850002174243 | K141059 | 000 |
| 00850002174236 | K141059 | 000 |
| 00850002174120 | K141059 | 000 |