Data / Medical devices / Strap, Head, Gas Mask / China
FDA-registered makers of Strap, Head, Gas Mask in China: 27 establishments
27 establishments in China are registered with the FDA to make Strap, Head, Gas Mask (product code BTK). 0 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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- Device
- Strap, Head, Gas Mask
- Product code
- BTK
- Country
- China
Makers of Strap, Head, Gas Mask in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Boen Healthcare Co., Ltd. | Suzhou Jiangsu, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Meiguan Care Products Technology Co.,ltd. | Changzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Hong De Medical Plastic Products Co. Ltd. | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flexicare Medical (dongguan) Ltd. | DONGGUAN CITY Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fortune Company Ltd. | Huizhou Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GaleMed (Xiamen) Co., Ltd. | XIAMEN Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei Wanli Protective Products Co.,ltd | xiantao Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hengshui Jingkang Medical Device Co.,Ltd. | Hengshui City Hebei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hynaut Health Technology Co., LTD. | Qingdao Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jianxing Shoe Co. Ltd. | Foshan City Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medex Medical Supplies Ltd. | China Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medsource Factory,inc. | CHANGZHOU Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medease Life Co.,Ltd | DANYANG Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Besmed Medical Equipment Corp. | NINGBO Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qidong Yongsheng Medical Products Factory | Qidong City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Gaohui Rubber And Plastic Products Co., Ltd | Shanghai, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Sany Pioneer Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Yimi Care Technology Co.,ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Shangchuang Technology Service Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Yuyue Medical Technology Co., Ltd | Suzhou Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sichuan AST Medical Equipment Co., Ltd | Luzhou City Sichuan, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Minhua Medical Equipment Co.,Ltd. | SuZhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tops Medical Articles Industries Nantong Inc | Qidong City Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Oti Electronic Industry Co., Ltd. | Xiamen Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhou Qionghua Sports Goods Co.,ltd | Yangzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Bangli Medical Products Co., Ltd. | YONGKANG CITY Zhejiang, China | 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.