Data / Medical devices / Malaysia / Karex Industries Sdn Bhd
Karex Industries Sdn Bhd: FDA-registered device maker in PONTIAN Johor, Malaysia, 16 510(k) clearances
Karex Industries Sdn Bhd is registered with the FDA (registration 9680135) in PONTIAN Johor, Malaysia. It lists 5 device types. The FDA files 16 510(k) clearances under its listings, the newest dated August 11, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9680135
- FEI number
- 1000535235
- Address
- PTD. 7906/7907, Taman Pontian Jaya BT. 34, Jalan Johor, PONTIAN Johor, Malaysia, 82000
- Owner or operator
- KAREX INDUSTRIES SDN BHD (9007040)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- January 3, 2011
- Registered through
- 2026
- Brand names listed
- Carex Hybrid Personal Lubricant
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Barrier, Std, Oral Sex | MSC | 2 | Contract manufacturer | accessdata.fda.gov |
| Condom | HIS | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Condom, Synthetic | MOL | 2 | Contract manufacturer | accessdata.fda.gov |
| Lubricant, Personal | NUC | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 11, 2023 | K223519 | Carex Hybrid Personal Lubricant | NUC | Substantially Equivalent | Karex Industries Sdn. Bhd. | accessdata.fda.gov |
| November 12, 2015 | K150743 | Water Based Personal Lubricant with Flavours | NUC | Substantially Equivalent | Karex Industries Sdn. Bhd. | accessdata.fda.gov |
| April 14, 2015 | K150072 | TheyFit Male Condom | HIS | Substantially Equivalent | Theyfit | accessdata.fda.gov |
| August 1, 2014 | K141059 | NATURAL RUBBER LATEX MALE CONDOMS | HIS | Substantially Equivalent | Karex Industries Sdn. Bhd. | accessdata.fda.gov |
| November 25, 2013 | K132597 | BLACK COLOURED CONDOM | HIS | Substantially Equivalent | Karex Industries Sdn. Bhd. | accessdata.fda.gov |
| September 27, 2013 | K122219 | THEYFIT MALE CONDOM | HIS | Substantially Equivalent | Theyfit | accessdata.fda.gov |
| July 3, 2012 | K113056 | ORANGE COLORED CONDOMS ORANGE SCENT | HIS | Substantially Equivalent | Karex Industries Sdn. Bhd. | accessdata.fda.gov |
| March 28, 2012 | K110690 | ONE PERSONAL LUBRICANT (SILICONE) | NUC | Substantially Equivalent | One | accessdata.fda.gov |
| February 1, 2012 | K110691 | ONE PERSONAL LUBRICANT (WATER BASED) | NUC | Substantially Equivalent | One | accessdata.fda.gov |
| December 7, 2011 | K113061 | LARGE/EXTRA LAGRE CONDOM | HIS | Substantially Equivalent | Karex Industries Sdn. Bhd. | accessdata.fda.gov |
| February 6, 2009 | K081886 | KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED | HIS | Substantially Equivalent | Karex Industries Sdn. Bhd. | accessdata.fda.gov |
| March 25, 2003 | K024324 | LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9 | HIS | Substantially Equivalent | Global Protection Corp. | accessdata.fda.gov |
| November 20, 1997 | K960552 | KNIGHT LIGHT NONLUBRICATED CONDOM | HIS | Substantially Equivalent | Global Protection Corp. | accessdata.fda.gov |
| February 14, 1997 | K964598 | TRUSTEX COLA FLAVORD CONDOM | HIS | Substantially Equivalent | Line One Laboratories | accessdata.fda.gov |
| December 6, 1995 | K944786 | RIA LATEX CONDOM & RIA COLOR CONDOMS (RED, GREEN, BLUE, ORANGE, PURPLE AND BLACK) | HIS | Substantially Equivalent | Line One Laboratories & Trading Co. | accessdata.fda.gov |
| August 14, 1991 | K902772 | PLEASURE PLUS | HIS | Substantially Equivalent | Medimix Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Condom
- All makers of Lubricant, Personal
- All makers of Barrier, Std, Oral Sex
- All makers of Condom, Synthetic
- All makers of Transducer, Ultrasonic, Diagnostic
Updated August 11, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.