Karex Industries Sdn Bhd
PONTIAN Johor, MY
KAREX INDUSTRIES SDN BHD appears in FDA device records in PONTIAN Johor, MY. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Karex Industries Sdn Bhd between 2007 and 2023. The busiest year on record is 2007, with 1. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2009 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K223519 | Carex Hybrid Personal Lubricant | NUC | Substantially Equivalent | |
| K150743 | Water Based Personal Lubricant with Flavours | NUC | Substantially Equivalent | |
| K141059 | NATURAL RUBBER LATEX MALE CONDOMS | HIS | Substantially Equivalent | |
| K132597 | BLACK COLOURED CONDOM | HIS | Substantially Equivalent | |
| K113056 | ORANGE COLORED CONDOMS ORANGE SCENT | HIS | Substantially Equivalent | |
| K113061 | LARGE/EXTRA LAGRE CONDOM | HIS | Substantially Equivalent | |
| K081886 | KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED | HIS | Substantially Equivalent | |
| K070830 | MALE NATURAL RUBBER LATEX CONDOM (WITH COLORING AND FLAVORING) | HIS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9680135 | 1000535235 | KAREX INDUSTRIES SDN BHD | PTD. 7906/7907, TAMAN PONTIAN JAYA, PONTIAN Johor 82000 MY | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain