Data / Medical devices / Condom / Malaysia
FDA-registered makers of Condom in Malaysia: 6 establishments
6 establishments in Malaysia are registered with the FDA to make Condom (product code HIS). 6 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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Makers of Condom in Malaysia
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Karex Industries Sdn Bhd | PONTIAN Johor, Malaysia | Contract manufacturer, Manufacturer | 12 | April 14, 2015 | 0 | 0 | 0 | api.fda.gov |
| Innolatex Sdn. Bhd | PORT KLANG Selangor, Malaysia | Manufacturer | 7 | February 21, 2006 | 0 | 0 | 0 | api.fda.gov |
| Pleasure Latex Products Sdn. Bhd. | JERAM Selangor, Malaysia | Contract manufacturer, Exporter to the US, Manufacturer | 7 | June 23, 2003 | 0 | 0 | 0 | api.fda.gov |
| Nulatex Sdn. Bhd. | Kluang Johor, Malaysia | Exporter to the US, Manufacturer | 2 | March 7, 2014 | 0 | 0 | 0 | api.fda.gov |
| Eurolatex Sdn Bhd | Kedah, Malaysia | Manufacturer | 1 | February 17, 2022 | 0 | 0 | 0 | api.fda.gov |
| Richter Rubber Technology Sdn. Bhd. | KUALA KETIL Kedah, Malaysia | Manufacturer | 1 | January 14, 2008 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.