The following data is part of a premarket notification filed by Karex Industries Sdn Bhd with the FDA for Male Natural Rubber Latex Condom (with Coloring And Flavoring).
| Device ID | K070830 |
| 510k Number | K070830 |
| Device Name: | MALE NATURAL RUBBER LATEX CONDOM (WITH COLORING AND FLAVORING) |
| Classification | Condom |
| Applicant | KAREX INDUSTRIES SDN BHD PTD. 7906/7907, TAMAN PONTIAN JAYA, BT. 34, JALAN JOHOR Pontian, Johor, MY 82000 |
| Contact | Leng Kian Goh |
| Correspondent | Leng Kian 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 | 2007-03-26 |
| Decision Date | 2007-05-08 |
| Summary: | summary |