Data / Medical devices / Condom / Thailand
FDA-registered makers of Condom in Thailand: 6 establishments
6 establishments in Thailand are registered with the FDA to make Condom (product code HIS). 5 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 Thailand
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Suretex, Ltd. | Amphur Phunphin Surat Thani, Thailand | Manufacturer, Specification developer | 13 | November 18, 2025 | 0 | 0 | 0 | api.fda.gov |
| Thai Nippon Rubber Industry Public Company Limited | Sriracha Chon Buri, Thailand | Contract manufacturer, Manufacturer | 10 | March 7, 2025 | 0 | 0 | 0 | api.fda.gov |
| Innolatex (thailand) Limited | Hat Yai Songkhla, Thailand | Contract manufacturer, Manufacturer | 8 | May 12, 2010 | 0 | 0 | 0 | api.fda.gov |
| Okamoto Rubber Products Co., Ltd. | PATHUMTHANI Pathum Thani, Thailand | Exporter to the US, Manufacturer | 4 | February 18, 2025 | 0 | 0 | 0 | api.fda.gov |
| SSL Manufacturing (thailand) Ltd. | BANGSAMAK,BANGPAKONG Chachoengsao, Thailand | Manufacturer, Specification developer | 4 | November 7, 2022 | 0 | 0 | 0 | api.fda.gov |
| Meiyume Manufacturing (Thailand) Limited | LAMLUKKA Pathum Thani, Thailand | Contract manufacturer | 0 | 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.