Data / Medical devices / Gown, Surgical / China
FDA-registered makers of Gown, Surgical in China: 57 establishments
57 establishments in China are registered with the FDA to make Gown, Surgical (product code FYA). 32 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.
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- Device
- Gown, Surgical
- Product code
- FYA
- Country
- China
Makers of Gown, Surgical in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Foshan Nanhai Plus Medical Co Ltd | Foshan Guangdong, China | Contract manufacturer, Foreign private label distributor, Manufacturer | 4 | November 14, 2022 | 0 | 0 | 0 | api.fda.gov |
| Exact Medical Manufacturing, Inc. | Changzhou Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 3 | June 12, 2012 | 0 | 0 | 0 | api.fda.gov |
| Gri Medical & Electronic Technology Co., Ltd. | JIAXING Zhejiang, China | Contract manufacturer, Manufacturer, Specification developer | 3 | December 8, 2017 | 0 | 0 | 0 | api.fda.gov |
| Yadu Medical (henan) Co., Ltd | Changyuan Henan, China | Contract manufacturer, Manufacturer | 3 | August 7, 2026 | 0 | 0 | 0 | api.fda.gov |
| Hubei Xinxin Non-Woven Co., Ltd | Xiantao Hubei, China | Manufacturer | 2 | April 20, 2026 | 0 | 0 | 0 | api.fda.gov |
| Weihai Hongyu Nonwoven Fabric Products Co.,Ltd | Weihai Shandong, China | Manufacturer | 2 | April 12, 2022 | 0 | 0 | 0 | api.fda.gov |
| Allmed Medical (hubei) Protective Products Co., Ltd | Zhijiang Hubei, China | Contract manufacturer, Manufacturer | 1 | September 29, 2022 | 0 | 0 | 0 | api.fda.gov |
| Anhui Medpurest Medical Technology Co.,ltd | Anqing Anhui, China | Exporter to the US, Manufacturer | 1 | August 21, 2021 | 0 | 0 | 0 | api.fda.gov |
| Changzhou Holymed Products Co., Ltd | CHANGZHOU Jiangsu, China | Contract manufacturer, Manufacturer, Specification developer | 1 | December 20, 2012 | 0 | 0 | 0 | api.fda.gov |
| Copioumed International, Inc. | TAIPEI Taiwan, China | Exporter to the US, Specification developer | 1 | February 26, 2026 | 0 | 0 | 0 | api.fda.gov |
| Exact Medical Manufacturing, Inc. | Changzhou Jiangsu, China | Contract manufacturer, Manufacturer | 1 | August 26, 2011 | 0 | 0 | 0 | api.fda.gov |
| Excellent Medical Technology Group Co., Ltd. | Suzhou Jiangsu, China | Complaint file establishment, Exporter to the US, Specification developer | 1 | June 3, 2022 | 0 | 0 | 0 | api.fda.gov |
| Fomed Industries Inc | Qian Jiang Hubei, China | Exporter to the US, Manufacturer | 1 | August 22, 2023 | 0 | 0 | 0 | api.fda.gov |
| Guangzhou Fuzelong Hygiene Material Co.,ltd. | Guangzhou Guangdong, China | Manufacturer | 1 | January 26, 2023 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou Jincheng Medical Supplies Manufacture Co., Ltd. | Hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 1 | March 11, 2011 | 0 | 0 | 0 | api.fda.gov |
| Henan Robestain Medical Products Co., Ltd. | Changyuan Henan, China | Manufacturer | 1 | December 13, 2021 | 0 | 0 | 0 | api.fda.gov |
| Hubei V-Medical Products Co., Ltd. | Xiantao Hubei, China | Exporter to the US, Manufacturer | 1 | January 16, 2019 | 0 | 0 | 0 | api.fda.gov |
| Hubei Wanli Protective Products Co.,ltd | xiantao Hubei, China | Exporter to the US, Manufacturer | 1 | October 24, 2021 | 0 | 0 | 0 | api.fda.gov |
| Jiangsu Guangda Medical Material Group Co., Ltd. | Haian Jiangsu, China | Manufacturer, Specification developer | 1 | December 12, 2012 | 0 | 0 | 0 | api.fda.gov |
| Kunshan Jiehong Nonwoven Product Co., Ltd. | KUNSHAN CITY Jiangsu, China | Contract manufacturer, Manufacturer | 1 | August 2, 2011 | 0 | 0 | 0 | api.fda.gov |
| Lianyungang Bronson Non-woven Products Co., Ltd. | LIANYUNGANG Jiangsu, China | Contract manufacturer, Manufacturer, Specification developer | 1 | November 12, 2009 | 0 | 0 | 0 | api.fda.gov |
| Nanning Tecbod Biological Technology Co.,ltd | Nanning Guangxi, China | Manufacturer | 1 | March 29, 2024 | 0 | 0 | 0 | api.fda.gov |
| Shandong Kangli Medical Equipment Technology Co., Ltd. | Zaozhuang Shandong, China | Manufacturer | 1 | May 22, 2020 | 0 | 0 | 0 | api.fda.gov |
| Shandong Zhushi Pharmaceutical Group Co., Ltd | Heze Shandong, China | Manufacturer | 1 | August 12, 2021 | 0 | 0 | 0 | api.fda.gov |
| Weihai Dishang Medical Technology Co.,ltd | Weihai Shandong, China | Contract manufacturer, Exporter to the US, Manufacturer | 1 | December 16, 2021 | 0 | 0 | 0 | api.fda.gov |
| Winner Medical Co., Ltd. | SHENZHEN Guangdong, China | Exporter to the US, Specification developer | 1 | September 19, 2022 | 0 | 0 | 0 | api.fda.gov |
| Wuhan Zonsen Medical Products Co., Ltd | Wuhan Hubei, China | Contract manufacturer, Exporter to the US, Manufacturer | 1 | December 15, 2021 | 0 | 0 | 0 | api.fda.gov |
| Xiamen Probtain Medical Technology Co.,ltd | Xiamen Fujian, China | Exporter to the US, Manufacturer | 1 | March 7, 2023 | 0 | 0 | 0 | api.fda.gov |
| Xiantao Dingcheng Nonwoven Products Co., Ltd. | Xiantao Hubei, China | Manufacturer | 1 | January 12, 2022 | 0 | 0 | 0 | api.fda.gov |
| Xiantao Rayxin Medical Products Co., Ltd. | XIANTAO Hubei, China | Manufacturer | 1 | January 16, 2019 | 0 | 0 | 0 | api.fda.gov |
| Xiantao Topmed Nonwoven Protective Products Co., Ltd | xiantao Hubei, China | Exporter to the US, Manufacturer | 1 | October 20, 2022 | 0 | 0 | 0 | api.fda.gov |
| Xiantao Zhibo Nonwoven Products Co.,ltd | Xiantao City Hubei, China | Exporter to the US, Manufacturer | 1 | August 22, 2023 | 0 | 0 | 0 | api.fda.gov |
| Anhui Ivymed Medical Products Co. Ltd | Xuancheng Anhui, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Binzhou Dingyue Clothing Company Limited | Binzhou Shandong, 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 | |
| Cobes Industries (Jinzhai) Co., Ltd. | Luan Anhui, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Shin Yi Healthcare Products Factory | DONG GUAN CITY Guangdong, China | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Donghai Xingchen Non-Woven Products Co., Ltd. | North Donghai Development Zone, Lianyungang Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fengyang Jiehong Nonwoven Product Co., Ltd. | Chuzhou City Anhui, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gri Medical & Electronic Technology Co., Ltd. | Wuhu Anhui, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heyuan Hong De Medical Products Co., Ltd. | Heyuan City Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hilo Healthcare China Co.,ltd | Lu'An Anhui, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangyin Puremed | Jiangyin Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu JianYu Health Medical Co., Ltd | Changzhou City Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kingstar Medical (Xianning) Co., Ltd. | Xianning City Hubei, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lianyungang Aiyeh Non-woven Products Co., Ltd. | Lianyungang Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lianyungang Anson Non-woven Product Co., Ltd. | Lianyungang Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu City Zhejiang, China | Contract manufacturer, Contract sterilizer | 0 | 0 | 1 | 0 | api.fda.gov | |
| S.E.S. Healthcare Products Co., Ltd. | Heifei Anhui, China | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| S.E.S. Healthcare Products Co., Ltd. | Huainan Anhui, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| S.E.S. Healthcare Products Co., Ltd. | Suzhou City Anhui, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| S.E.S. Healthcare Products Co., Ltd. | Huainan City Anhui, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Baili Medical Supplies Co.,ltd | Suzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sino Protection (Hefei) Medical Products Co. ltd. | HEFEI Anhui, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sino Protection (Liuan) Medical Products Co., Ltd. | LIU AN Anhui, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Meccan Import and Export Corp. | Suzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Winner Medical (Chongyang) Co., Ltd. | Chongyang Hubei, 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.