Data / Medical devices / Mask, Surgical / China
FDA-registered makers of Mask, Surgical in China: 103 establishments
103 establishments in China are registered with the FDA to make Mask, Surgical (product code FXX). 81 have 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, Surgical
- Product code
- FXX
- Country
- China
Makers of Mask, Surgical in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Guangdong Kingfa Medical Sci.&tech. Co., Ltd. | Qingyuan Guangdong, China | Manufacturer | 5 | November 7, 2023 | 0 | 0 | 0 | api.fda.gov |
| Dongguan Sure On Plastic and Fiber Product Co., Ltd. | DONG GUAN CITY Guangdong, China | Contract manufacturer, Manufacturer | 4 | January 5, 2026 | 0 | 0 | 0 | api.fda.gov |
| Makrite Hubei Industrial Co., Ltd. | Chibi High-Tech Zone Hubei, China | Contract manufacturer, Manufacturer | 4 | January 5, 2026 | 0 | 0 | 0 | api.fda.gov |
| Winner Medical Co., Ltd. | SHENZHEN Guangdong, China | Exporter to the US, Specification developer | 4 | June 18, 2025 | 0 | 0 | 0 | api.fda.gov |
| Xiantao Rayxin Medical Products Co., Ltd. | XIANTAO Hubei, China | Contract manufacturer, Manufacturer | 4 | June 15, 2016 | 0 | 0 | 0 | api.fda.gov |
| AOK Tooling Limited | Shen Zhen Guangdong, China | Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer | 3 | July 27, 2022 | 0 | 0 | 0 | api.fda.gov |
| Crown Name Disposable Hygiene Products Fty. Ltd. | Wuhan Hubei, China | Exporter to the US, Manufacturer | 3 | July 21, 2021 | 0 | 0 | 0 | api.fda.gov |
| Qinhuangdao Taizhi Medical Technology Co., Ltd | Qinhuangdao Hebei, China | Manufacturer | 3 | February 7, 2023 | 0 | 0 | 0 | api.fda.gov |
| Wuhan Huaxin Nonwoven Co., Ltd | Wuhan Hubei, China | Manufacturer | 3 | March 8, 2022 | 0 | 0 | 0 | api.fda.gov |
| Hubei V-Medical Products Co., Ltd. | Xiantao Hubei, China | Exporter to the US, Manufacturer | 2 | June 15, 2016 | 0 | 0 | 0 | api.fda.gov |
| Hubei Wanli Protective Products Co.,ltd | xiantao Hubei, China | Exporter to the US, Manufacturer | 2 | April 6, 2022 | 0 | 0 | 0 | api.fda.gov |
| Hubei Haixin Protective Products Group Co.,Ltd | Songzi City Hubei, China | Exporter to the US, Manufacturer | 2 | September 26, 2022 | 0 | 0 | 0 | api.fda.gov |
| Jingzhou Haixin Green Cross Medical Products Co.,ltd | Jingzhou Hubei, China | Exporter to the US, Manufacturer | 2 | September 26, 2022 | 0 | 0 | 0 | api.fda.gov |
| Rizhao Sanqi Medical & Health Articles Co., Ltd | Rizhao Shandong, China | Exporter to the US, Manufacturer | 2 | March 24, 2022 | 0 | 0 | 0 | api.fda.gov |
| Shanghai Hua En Industrial Co Ltd | Shanghai, China | Manufacturer | 2 | August 17, 2022 | 0 | 0 | 0 | api.fda.gov |
| Xiamen Probtain Medical Technology Co.,ltd | Xiamen Fujian, China | Exporter to the US, Manufacturer | 2 | July 2, 2021 | 0 | 0 | 0 | api.fda.gov |
| Xiantao Zhibo Nonwoven Products Co.,ltd | Xiantao City Hubei, China | Exporter to the US, Manufacturer | 2 | March 12, 2022 | 0 | 0 | 0 | api.fda.gov |
| Zhejiang Lanhine Medical Products Ltd. | Cixi City Zhejiang, China | Exporter to the US, Manufacturer | 2 | September 23, 2021 | 0 | 0 | 0 | api.fda.gov |
| Zhende Medical Co., Ltd. | SHAOXING Zhejiang, China | Contract manufacturer, Manufacturer | 2 | April 28, 2021 | 0 | 0 | 0 | api.fda.gov |
| Allmed Medical Products Co., Ltd. | Zhijiang City Hubei, China | Manufacturer | 1 | March 10, 2021 | 0 | 0 | 0 | api.fda.gov |
| Arrow Medsource Group Limited | Hongkong, China | Exporter to the US, Specification developer | 1 | July 17, 2013 | 0 | 0 | 0 | api.fda.gov |
| Anqing Mayfield Medical Limited | Anqing Anhui, China | Exporter to the US, Manufacturer | 1 | January 3, 2023 | 0 | 0 | 0 | api.fda.gov |
| Beatles Medical Supplies (xiantao) Co., Ltd | Xiantao Hubei, China | Exporter to the US, Manufacturer | 1 | January 12, 2026 | 0 | 0 | 0 | api.fda.gov |
| BH Medical Products Co., Ltd | Changzhou City Jiangsu, China | Manufacturer | 1 | June 22, 2015 | 0 | 0 | 0 | api.fda.gov |
| Changzhou DSB Medical Co., Ltd | Changzhou City Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 1 | July 15, 2021 | 0 | 0 | 0 | api.fda.gov |
| Changzhou Holymed Products Co., Ltd | CHANGZHOU Jiangsu, China | Manufacturer | 1 | July 7, 2021 | 0 | 0 | 0 | api.fda.gov |
| Copioumed International, Inc. | TAIPEI Taiwan, China | Manufacturer | 1 | September 3, 1997 | 0 | 0 | 0 | api.fda.gov |
| Foshan Nanhai Plus Medical Co Ltd | Foshan Guangdong, China | Contract manufacturer, Manufacturer | 1 | January 26, 2022 | 0 | 0 | 0 | api.fda.gov |
| Fomed Industries Inc | Qian Jiang Hubei, China | Manufacturer | 1 | April 25, 2022 | 0 | 0 | 0 | api.fda.gov |
| Guangdong Golden Leaves Technology Development Co., Ltd. | Dongguan Guangdong, China | Manufacturer | 1 | November 23, 2022 | 0 | 0 | 0 | api.fda.gov |
| Guangzhou Fuzelong Hygiene Material Co.,ltd. | Guangzhou Guangdong, China | Contract manufacturer, Manufacturer | 1 | May 19, 2023 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou Qianzhiya Sanitary Products Co.,ltd | Hangzhou Zhejiang, China | Manufacturer | 1 | March 25, 2021 | 0 | 0 | 0 | api.fda.gov |
| Hantech Medical Device Co., Ltd. | Cixi Zhejiang, China | Manufacturer | 1 | September 1, 2022 | 0 | 0 | 0 | api.fda.gov |
| Henan Chaoya Medical Equipment Co., Ltd. | Zhengzhou Henan, China | Manufacturer | 1 | June 1, 2023 | 0 | 0 | 0 | api.fda.gov |
| Henan Huibo Medical Co., Ltd | Nanyang City Henan, China | Contract manufacturer, Manufacturer | 1 | November 26, 2021 | 0 | 0 | 0 | api.fda.gov |
| Hubei Deming Healthcare Products Co.,ltd. | Xiantao Hubei, China | Manufacturer | 1 | May 27, 2019 | 0 | 0 | 0 | api.fda.gov |
| Hubei Deming Healthcare Products Co.,ltd.first Branch | Xiantao City Hubei, China | Exporter to the US, Manufacturer | 1 | May 27, 2019 | 0 | 0 | 0 | api.fda.gov |
| Hubei Huanfu Plastic Products Co., Ltd | HANCHUAN CITY Hubei, China | Manufacturer | 1 | November 14, 2021 | 0 | 0 | 0 | api.fda.gov |
| Hubei Kangning Protective Products Co., Ltd | XIanTao Hubei, China | Exporter to the US, Manufacturer | 1 | July 24, 2021 | 0 | 0 | 0 | api.fda.gov |
| Hubei Kimsoul Industrial Co.,ltd | Xiantao Hubei, China | Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor, Specification developer | 1 | December 15, 2021 | 0 | 0 | 0 | api.fda.gov |
| Hubei Qianjiang Kingphar Medical Material Co., Ltd | Qianjiang, Hubei, China | Manufacturer | 1 | July 19, 2022 | 0 | 0 | 0 | api.fda.gov |
| Hubei Xinxin Non-Woven Co., Ltd | Xiantao Hubei, China | Manufacturer | 1 | January 28, 2022 | 0 | 0 | 0 | api.fda.gov |
| Hubei Yi-Ya Protective Products Co., Ltd. | Xiantao Hubei, China | Manufacturer | 1 | October 4, 2021 | 0 | 0 | 0 | api.fda.gov |
| Hynaut Health Technology Co., LTD. | Qingdao Shandong, China | Manufacturer | 1 | May 7, 2021 | 0 | 0 | 0 | api.fda.gov |
| Jiangsu Medplus Non-Woven Manufacturer Co.,ltd. | Siyang Jiangsu, China | Manufacturer | 1 | February 10, 2021 | 0 | 0 | 0 | api.fda.gov |
| Jiangxi 3L Medical Products Group Co., Ltd | Nanchang Jiangxi, China | Manufacturer | 1 | September 25, 2020 | 0 | 0 | 0 | api.fda.gov |
| Jiangxi Hongda Medical Equipment Group Ltd. | Nanchang Jiangxi, China | Manufacturer | 1 | October 8, 2021 | 0 | 0 | 0 | api.fda.gov |
| Jiangxi Sanxin Medtec Co.,ltd. | Nanchang Jiangxi, China | Exporter to the US, Manufacturer | 1 | January 4, 2021 | 0 | 0 | 0 | api.fda.gov |
| Jinhua Jingdi Medical Supplies Co.,ltd | Jinhua Zhejiang, China | Manufacturer | 1 | April 23, 2021 | 0 | 0 | 0 | api.fda.gov |
| Jiujiang Huada Medical Dressing Co., Ltd. | JIUJIANG Jiangxi, China | Manufacturer | 1 | January 25, 2018 | 0 | 0 | 0 | api.fda.gov |
| Juntech (jiaxing) Healthcare Materials Co., Ltd. | Nanhu District, Jiaxing Zhejiang, China | Manufacturer | 1 | June 4, 2021 | 0 | 0 | 0 | api.fda.gov |
| Jiangsu Guangda Medical Material Group Co., Ltd. | Haian Jiangsu, China | Manufacturer | 1 | April 15, 2021 | 0 | 0 | 0 | api.fda.gov |
| Jiangsu JianYu Health Medical Co., Ltd | Changzhou City Jiangsu, China | Manufacturer | 1 | December 30, 2020 | 0 | 0 | 0 | api.fda.gov |
| Jiangsu Nanfang Medical Co., Ltd. | CHANGZHOU Jiangsu, China | Manufacturer | 1 | January 19, 2022 | 0 | 0 | 0 | api.fda.gov |
| Jiangsu Newvalue Medical Products Co., Ltd. | Taizhou Jiangsu, China | Exporter to the US, Manufacturer | 1 | January 6, 2021 | 0 | 0 | 0 | api.fda.gov |
| Kingstar Medical (Xianning) Co., Ltd. | Xianning City Hubei, China | Manufacturer | 1 | October 2, 2023 | 0 | 0 | 0 | api.fda.gov |
| Nanjing 3H Medical Products Co.,ltd. | NANJING Jiangsu, China | Manufacturer | 1 | November 24, 2021 | 0 | 0 | 0 | api.fda.gov |
| Qing Dao Tong Hui Clothing Co., Ltd. | QING DAO, SHAN DONG Shandong, China | Manufacturer | 1 | June 7, 2004 | 0 | 0 | 0 | api.fda.gov |
| Qingdao Bestex Rubber & Plastic Products Co., Ltd | PINGDU, QINGDAO Shandong, China | Contract manufacturer, Exporter to the US, Manufacturer | 1 | May 26, 2022 | 0 | 0 | 0 | api.fda.gov |
| Rfx+care Manufacturing Co., Ltd. | Shaoxing Zhejiang, China | Exporter to the US, Manufacturer | 1 | June 2, 2021 | 0 | 0 | 0 | api.fda.gov |
| Safeway Industry Healthcare | Xiantao Hubei, China | Manufacturer | 1 | June 22, 2021 | 0 | 0 | 0 | api.fda.gov |
| Shandong Haidike Medical Products Co., Ltd | Heze Shandong, China | Manufacturer | 1 | June 14, 2021 | 0 | 0 | 0 | api.fda.gov |
| Shandong Intco Medical Products Co Ltd | Qingzhou Shandong, China | Manufacturer | 1 | March 30, 2021 | 0 | 0 | 0 | api.fda.gov |
| Shandong Zhushi Pharmaceutical Group Co., Ltd | Heze Shandong, China | Contract manufacturer, Contract sterilizer, Exporter to the US, Manufacturer | 1 | September 22, 2021 | 0 | 0 | 0 | api.fda.gov |
| Shanghai Jianzhong Medical Packaging Co., Ltd. | Shanghai, China | Specification developer | 1 | February 12, 2021 | 0 | 0 | 0 | api.fda.gov |
| U-Play Products Corporation | wuhu Anhui, China | Exporter to the US, Manufacturer | 1 | March 4, 2021 | 0 | 0 | 0 | api.fda.gov |
| V&Q Manufacturing Corporation | Xiantao Hubei, China | Manufacturer | 1 | January 25, 2018 | 0 | 0 | 0 | api.fda.gov |
| Weihai Dishang Medical Technology Co.,ltd | Weihai Shandong, China | Exporter to the US, Manufacturer | 1 | October 24, 2021 | 0 | 0 | 0 | api.fda.gov |
| Wellmien Healthcare Tech.(suzhou) Co., Ltd. | Suzhou Jiangsu, China | Exporter to the US, Specification developer | 1 | August 9, 2010 | 0 | 0 | 0 | api.fda.gov |
| Wuhan Zonsen Medical Products Co., Ltd | Wuhan Hubei, China | Contract manufacturer, Exporter to the US, Manufacturer | 1 | December 16, 2022 | 0 | 0 | 0 | api.fda.gov |
| Wuxi Yushou Medical Appliances Co., Ltd | Wuxi City Jiangsu, China | Manufacturer | 1 | January 18, 2022 | 0 | 0 | 0 | api.fda.gov |
| Weihai Hongyu Nonwoven Fabric Products Co.,Ltd | Weihai Shandong, China | Manufacturer | 1 | December 3, 2021 | 0 | 0 | 0 | api.fda.gov |
| Wellmed Dental Medical Supply Co., Ltd | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 1 | November 4, 2022 | 0 | 0 | 0 | api.fda.gov |
| Winner Medical (Huanggang) Co., Ltd. | Huanggang Hubei, China | Contract manufacturer, Repackager or relabeler | 1 | November 3, 1989 | 0 | 0 | 0 | api.fda.gov |
| Xiantao Daoqi Plastic Co., Ltd. | Xiantao Hubei, China | Manufacturer | 1 | October 18, 2024 | 0 | 0 | 0 | api.fda.gov |
| Xiantao Dingcheng Nonwoven Products Co., Ltd. | Xiantao Hubei, China | Manufacturer | 1 | November 16, 2021 | 0 | 0 | 0 | api.fda.gov |
| Xiantao S&J Protective Products Co., Ltd | Xiantao Hubei, China | Manufacturer | 1 | August 19, 2021 | 0 | 0 | 0 | api.fda.gov |
| Xiantao Sanda Industrial Co., Ltd | Xiantao Hubei, China | Exporter to the US, Manufacturer | 1 | December 13, 2022 | 0 | 0 | 0 | api.fda.gov |
| Xiantao Topmed Nonwoven Protective Products Co., Ltd | xiantao Hubei, China | Exporter to the US, Manufacturer | 1 | July 22, 2022 | 0 | 0 | 0 | api.fda.gov |
| Xiantao Zhongyi Safety & Protection Products Co.,Ltd. | Xiantao City Hubei, China | Manufacturer | 1 | March 26, 2021 | 0 | 0 | 0 | api.fda.gov |
| Zhejiang Hongyu Medical Commodity Co., Ltd. | YIWU Zhejiang, China | Exporter to the US, Manufacturer | 1 | August 3, 2021 | 0 | 0 | 0 | api.fda.gov |
| A.R. Medicom Inc. (Shanghai) Co., Ltd. | Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aimmax Medical Products Co.,ltd. | Shiyan Hubei, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Allmed Medical (hubei) Protective Products Co., Ltd | Zhijiang Hubei, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anhui Ares Medical Technology Co.,ltd. | Tianchang Anhui, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Copious Intl., Inc. | Heyuan, Guangdong Province, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Shin Yi Healthcare Products Factory | DONG GUAN CITY Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| H&K International Trade Limited (china) | jinhua Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei Weikang Protective Products Co.ltd | XIANTAO Hubei, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Jsongmed Medical Material Co.,ltd | jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| JM Medical Co., Ltd. | Liaocheng Shandong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lianyungang Bronson Non-woven Products Co., Ltd. | LIANYUNGANG Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nantong Jianan Medical Products Co.,ltd | Nantong Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primed Liyang Medical Products Manufacturing Co., Ltd. | Liyang Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu City Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Avon Textile Co., Ltd. | Suzhou City Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tianchang Jiarui Packaging Material Co., Ltd. | Tianchang Anhui, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tissue Protective Products Co., Ltd | tianmen Hubei, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wellpower Sporting Goods Co., Ltd. | Dong Guan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Chuanfutang Pharmaceutical Co.,ltd | xiamen Fujian, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xianning Eco Medical Articles Co., Ltd. | Xianning Hubei, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xuchang Zhende Surgical Dressing Co.,ltd. | Xuchang Henan, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhangjiagang Jiayin Sanitary Products Co., Ltd. | Zhangjiagang City Jiangsu, China | Contract 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.