The following data is part of a premarket notification filed by Karex Industries Sdn Bhd with the FDA for Karex Industries Male Natural Rubber Latex Condom, Non-spermicidal, Lubricated And Non Lubricated.
| Device ID | K081886 |
| 510k Number | K081886 |
| Device Name: | KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED |
| 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 | 2008-07-02 |
| Decision Date | 2009-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00302340991124 | K081886 | 000 |
| 00302340302777 | K081886 | 000 |
| 40302340082448 | K081886 | 000 |
| 40302340856384 | K081886 | 000 |
| 40302340856391 | K081886 | 000 |
| 40302340856407 | K081886 | 000 |
| 40302340856414 | K081886 | 000 |
| 00850002174373 | K081886 | 000 |
| 00850002174410 | K081886 | 000 |
| 00850002174663 | K081886 | 000 |
| 00850002174694 | K081886 | 000 |
| 00850002174779 | K081886 | 000 |
| 00850002174861 | K081886 | 000 |
| 00850002174892 | K081886 | 000 |
| 10302340090008 | K081886 | 000 |
| 20302340302771 | K081886 | 000 |
| 00302340096584 | K081886 | 000 |