Data / Medical devices / Condom / China
FDA-registered makers of Condom in China: 8 establishments
8 establishments in China are registered with the FDA to make Condom (product code HIS). 7 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 China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Qingdao London Durex Co., Ltd. | Qingdao Shandong, China | Manufacturer | 2 | November 7, 2022 | 0 | 0 | 0 | api.fda.gov |
| Suzhou Colour-way New Material Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 2 | November 28, 2022 | 0 | 0 | 0 | api.fda.gov |
| Dalian Latex Co Ltd | Dalian Liaoning, China | Contract manufacturer, Manufacturer | 1 | October 24, 2008 | 0 | 0 | 0 | api.fda.gov |
| Guangzhou Double One Latex Products Co., Ltd. | GUANGZHOU CITY Guangdong, China | Contract manufacturer, Manufacturer | 1 | June 6, 1990 | 0 | 0 | 0 | api.fda.gov |
| Shanghai Jinxiang Latex Products Co., Ltd. | Shanghai, China | Contract manufacturer, Exporter to the US, Manufacturer | 1 | March 1, 2005 | 0 | 0 | 0 | api.fda.gov |
| Shanghai Personage Hygiene Products Co.,ltd. | Shanghai, China | Manufacturer | 1 | August 5, 2022 | 0 | 0 | 0 | api.fda.gov |
| Shaoguan Regenex Pharmaceutical Co., Ltd. | Shaoguan Guangdong, China | Manufacturer | 1 | July 11, 2025 | 0 | 0 | 0 | api.fda.gov |
| Suzhou Armocon Technology Co., Ltd. | Jiangsu, China | 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.