Data / Medical devices / Mask, Oxygen, Non-Rebreathing / China
FDA-registered makers of Mask, Oxygen, Non-Rebreathing in China: 60 establishments
60 establishments in China are registered with the FDA to make Mask, Oxygen, Non-Rebreathing (product code KGB). 1 has a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Device
- Mask, Oxygen, Non-Rebreathing
- Product code
- KGB
- Country
- China
Makers of Mask, Oxygen, Non-Rebreathing in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Laerdal Medical (suzhou) Co., Ltd. | 215009 Suzhou Jiangsu Province, China | Manufacturer | 1 | December 2, 1993 | 0 | 0 | 0 | api.fda.gov |
| Amsino Medical (kunshan) Co., Ltd. | KUNSHAN CITY Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anji Hongde Medical Products Co., Ltd. | HUZHOU Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anji Spenq Industrial Co., Ltd. | Huzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anping Guardian Medical Equipment Co.,ltd | Hengshui Hebei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boen Healthcare Co., Ltd. | Suzhou Jiangsu, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bonree Medical Co., Ltd | Zhongshan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan City Risen Medical Products Co., Ltd | Dongguan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan City Ruimi Gift Products Co Ltd | Dongguan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Emsrun Group | Wuxi Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Evereast Medical Products Group Co., Ltd | Changyuan City Henan, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FIRSTAR HEALTHCARE Company Limited (Guangzhou) | Guangzhou 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 | |
| Flying Tooling Engineering Limited | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gauke (hubei) Healthcare Co., Ltd | Huanggang City Hubei, China | Foreign private label distributor, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gcmedica Enterprise Ltd.(wuxi) | WUXI Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GFA Production Xiamen Co., Ltd. | Tong An, Xiamen Fujian, China | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Ecan Medical Co,ltd | Guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Nuoning Medical Supplies Co.,ltd | Guangzhou Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GaleMed (Xiamen) Co., Ltd. | XIAMEN Fujian, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Aosi Healthcare Co., Ltd. | HANGZHOU Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Rollmed Co.,ltd. | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Shanyou Medical Equipment Co.,ltd | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Superds Industry Co., Ltd. | Hangzhou City Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hitec Medical Co., Ltd | Shanghai, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huzhou Junda Industry Co., Ltd. | Anji Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Jinlin Medical Appliances Co., Ltd. | Hangzhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hynaut Health Technology Co., LTD. | Qingdao Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intersurgical Medical Apparatus (changzhou) Co., Ltd. | Changzhou City Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. | Shuyang Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jinyuan Medical Equipment(tianjin)co.,ltd | Tianjin, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Koo (Shanghai) Industries Co., Ltd | Songjiang Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nantong City Yojo Medical Products Co., Ltd. | Haimen Jiangsu, China | Contract manufacturer, 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 Chibanda Imp &exp Co, Ltd | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Hanyue Medical Technology Co.,ltd | CIXI CITY Zhejiang, China | Contract manufacturer, Exporter to the US, 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 | |
| Ningbo Mflab Medical Instruments Co., Ltd. | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Runmai Medical Technology Co., Ltd. | Cixi Zhejiang, China | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Shengyurui Medical Appliance Co. | Ningbo Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Tianbo First Aid Product Co., Ltd. | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Great Mountain Medical Instruments Co.,Ltd | Ningbo Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Polymed (xiamen) Plastic Industrial Co.,ltd. | XIAMEN Fujian, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Saferlife Products Co.,ltd. | Guangzhou Guangdong, China | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shaoxing Jiancheng Medical Products Co., Ltd. | Shaoxing Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Bi-Rich Medical Devices Co., Ltd | Shenzhen City Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Taizhou Rich Medical Products Co., Ltd. | TAIZHOU Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Taizhou Xinkang Medical Materials Co., Ltd | Taizhou Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tiger Medical Group | Shanghai, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tylenol Medical Instruments Co., Ltd. | Zhongshan Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Welbreath Technology Co.,ltd | baoding Hebei, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Well Lead Medical Co. Ltd | GUANGZHOU Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Tianzuo Medical Co., Ltd. | Xiamen Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yiwu Daqida Plastic Products Co., Ltd. | Yiwu Zhejiang, China | Exporter to the US, Foreign private label distributor, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Baite Medical Appliances Co., Ltd. | Huzhou City Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Lidesen Medical Instrument Co., Ltd | Hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Mediunion Healthcare Group Co.,ltd | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhongshan Hongze Medical Technology Co., Ltd. | Zhongshan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Medtec Medical devices Co., Ltd | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.