Suit, Surgical (FXO): 95 FDA-registered makers in 11 countries

Name: FDA-registered makers of Suit, Surgical
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

95 establishments in 11 countries are registered with the FDA to make Suit, Surgical (product code FXO, Class 1, 21 CFR 878.4040). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on May 5, 1992, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: FXO
Device class: 1
Regulation: 878.4040
Medical specialty: General, Plastic Surgery

Makers by country

Country	Makers
China	64
Vietnam	8
United States	6
Bangladesh	3
Cambodia	3
Mexico	3
Pakistan	3
Taiwan	2
El Salvador	1
Peru	1
Thailand	1

Makers of Suit, Surgical

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Maker	Location	Role	Source
American Dawn Inc.	Compton, CA, United States	Specification developer	api.fda.gov
An Lanh Investment And Trading Company Limited	Thanh Nam Ward Ninh Binh, Vietnam	Exporter to the US, Manufacturer	api.fda.gov
Angeline Group Ltd.	New Taipei City, Taiwan	Manufacturer	api.fda.gov
Anhui Ivymed Medical Products Co. Ltd	Xuancheng Anhui, China	Contract manufacturer	api.fda.gov
Anhui Dajiang Medical Products Co.,Ltd.	chuzhou Anhui, China	Manufacturer	api.fda.gov
Apex Aseptic Products	Voorhees, NJ, United States	Specification developer	api.fda.gov
Beijing ZKSK Technology Co., Ltd.	beijing, China	Manufacturer	api.fda.gov
Beximco Ppe Limited	Dhaka Dhaka(Division), Bangladesh	Contract manufacturer	api.fda.gov
Boen Healthcare Co., Ltd.	Suzhou Jiangsu, China	Exporter to the US, Specification developer	api.fda.gov
Copious (cambodia) International Inc.	Takeo, Cambodia	Contract manufacturer	api.fda.gov
Crown Name Disposable Hygiene Products Fty. Ltd.	Wuhan Hubei, China	Contract manufacturer, Manufacturer	api.fda.gov
Dalian Rongbang Medical Healthy Devices Co Ltd	Dalian Liaoning, China	Manufacturer	api.fda.gov
Degasa, S.A. De C.V.	Jiutepec Morelos, Mexico	Manufacturer	api.fda.gov
Dongguan Shin Yi Healthcare Products Factory	DONG GUAN CITY Guangdong, China	Contract manufacturer	api.fda.gov
Dragon Medical Co.,Ltd	Suzhou City Jiangsu, China	Manufacturer	api.fda.gov
Ecollink Non-Woven Company Limited	Hongkong, China	Exporter to the US, Manufacturer	api.fda.gov
Environstar Group Company Limited	Hung Yen Province, Vietnam	Contract manufacturer	api.fda.gov
Foshan Niceday Sanitary Products Co., Ltd.	Foshan Guangdong, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Fullstar Non-Woven Products Co.,ltd.	Xiantao City Hubei, China	Exporter to the US, Manufacturer	api.fda.gov
Fung Lead Medical & Sports Co., Ltd.	Nantou City, Taiwan	Exporter to the US, Manufacturer	api.fda.gov
Fomed Industries Inc	Qian Jiang Hubei, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
GLX Medical Devices Company Limited	Bien Hoa Dong Nai, Vietnam	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Guangdong Kangshen Medical Technology Co.,ltd.	ZHAOQING Guangdong, China	Manufacturer	api.fda.gov
Haimen Shengbang Laboratory Equipment Co., Ltd	Haimen Jiangsu, China	Manufacturer	api.fda.gov
Hanh Minh Manufacturing Trading Company Limited	Bien Hoa Dong Nai, Vietnam	Manufacturer, Repackager or relabeler	api.fda.gov
Hubei Feiteng Protective Products Co.,ltd	Xiantao Hubei, China	Manufacturer	api.fda.gov
Hubei Huanfu Plastic Products Co., Ltd	HANCHUAN CITY Hubei, China	Manufacturer	api.fda.gov
Hubei Kangcheng Non-Woven Co., Ltd	XIANTAO Hebei, China	Exporter to the US, Manufacturer	api.fda.gov
Hubei Origincare Medical Products Co., Ltd.	Xiantao city Hubei, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Hubei Weikang Protective Products Co.ltd	XIANTAO Hubei, China	Contract manufacturer, Manufacturer	api.fda.gov
Hubei Haixin Protective Products Group Co.,Ltd	Songzi City Hubei, China	Manufacturer	api.fda.gov
Hubei Yi-Ya Protective Products Co., Ltd.	Xiantao Hubei, China	Manufacturer	api.fda.gov
Hubei Yiye Plastics Co. LTD	Tianmen Hubei, China	Manufacturer	api.fda.gov
Icat S.A. De C.V.	San Salvador, El Salvador	Contract manufacturer, Exporter to the US	api.fda.gov
Insumos Desechables Para La Salud S.A. De CV.	Tecoh Yucatan, Mexico	Manufacturer	api.fda.gov
Jiangsu Hanfang Textile Technology Co., Ltd	Xuzhou City Jiangsu, China	Contract manufacturer	api.fda.gov
Jiangsu Medplus Non-Woven Manufacturer Co.,ltd.	Siyang Jiangsu, China	Manufacturer	api.fda.gov
Jianyi Enterprises	TIANMEN Hubei, China	Manufacturer	api.fda.gov
Jingzhou Haixin Green Cross Medical Products Co.,ltd	Jingzhou Hubei, China	Contract manufacturer, Manufacturer	api.fda.gov
Jiangsu JianYu Health Medical Co., Ltd	Changzhou City Jiangsu, China	Contract manufacturer, Manufacturer	api.fda.gov
Kunshan Jiehong Nonwoven Product Co., Ltd.	KUNSHAN CITY Jiangsu, China	Manufacturer	api.fda.gov
Lucky Textile Mills Limited	KARACHI Sindh, Pakistan	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
La Ada de Acuna	CIUDAD DE ACUNA Coahuila, Mexico	Manufacturer	api.fda.gov
Master & Frank (cambodia) Co., Ltd.	Angsnoul Kandal, Cambodia	Contract manufacturer	api.fda.gov
Ningbo Chibanda Imp &exp Co, Ltd	Ningbo Zhejiang, China	Manufacturer	api.fda.gov
O&M Halyard, Inc.	Alpharetta, GA, United States	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	api.fda.gov
Operating Theatre Medical Bangladesh Company Limited	Kaliakair Gazipur, Bangladesh	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Prescient Logistics LLC	Sanford, FL, United States	Specification developer	api.fda.gov
Qing Dao Tong Hui Clothing Co., Ltd.	QING DAO, SHAN DONG Shandong, China	Manufacturer	api.fda.gov
Qingdao Bestex Rubber & Plastic Products Co., Ltd	PINGDU, QINGDAO Shandong, China	Exporter to the US, Manufacturer	api.fda.gov
Quang Nam Medical Devices Factory Branch Of Danameco Medical Joint Stock Corporation	Dien Ban Bac Ward Da Nang, Vietnam	Contract manufacturer, Manufacturer	api.fda.gov
Qingdao Likangyuan Medical Device Co.,Ltd.	Qingdao Shandong, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
R & G Seguridad E Higiene Industrial S.A.C.	VENTANILLA Lima(Province), Peru	Manufacturer	api.fda.gov
Samaritan Textile (cambodia) Co., Ltd.	Phnom Penh, Cambodia	Manufacturer	api.fda.gov
Sanmu (vietnam) Protective Products Co., Ltd	Duc Hoa Commune Tay Ninh, Vietnam	Exporter to the US, Manufacturer	api.fda.gov
Shandong Zhushi Pharmaceutical Group Co., Ltd	Heze Shandong, China	Manufacturer	api.fda.gov
Shanghai Link Instruments Co.,ltd	Changzhou City Jiangsu, China	Manufacturer	api.fda.gov
Shunde Lucas Industries	Foshan City Guangdong, China	Manufacturer	api.fda.gov
Silverfox Corporation Limited	Jiangmen Guangdong, China	Manufacturer	api.fda.gov
Stevimed Medical Joint Stock Company	Can Giuoc Commune Tay Ninh, Vietnam	Manufacturer	api.fda.gov
Sunkiss Healthcare(zhejiang) Co., Ltd	HANGZHOU Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Suzhou Sunmed Co., Ltd	SUZHOU CITY Jiangsu, China	Exporter to the US, Manufacturer	api.fda.gov
Shanghai Joy Crown Industry Co., Ltd	Pu Dong New Area Shanghai, China	Contract manufacturer	api.fda.gov
Sloan Medical	Omaha, NE, United States	Manufacturer, Specification developer	api.fda.gov
Sultex Industries	karachi Sindh, Pakistan	Manufacturer	api.fda.gov
Thai Hospital Products Co., Ltd.	BANGPUD, PAKKRED, Nonthaburi, Thailand	Contract manufacturer, Manufacturer	api.fda.gov
Tissue Protective Products Co., Ltd	tianmen Hubei, China	Manufacturer	api.fda.gov
Taizhou Jiahong Glasses Co.,Ltd	Taizhou Zhejiang, China	Exporter to the US, Manufacturer	api.fda.gov
U-Play Products Corporation	wuhu Anhui, China	Exporter to the US, Manufacturer	api.fda.gov
U.S. Pacific Nonwovens Technology (Dongguan) Ltd	Dongguan City Guangdong, China	Contract manufacturer, Manufacturer	api.fda.gov
United towel Exporters	Karachi Sindh, Pakistan	Manufacturer	api.fda.gov
V&Q Manufacturing Corporation	Xiantao Hubei, China	Manufacturer	api.fda.gov
Vien Phat Import Export Service Trading Joint Stock Company	Ben Thanh Ward Ho Chi Minh, Vietnam	Manufacturer	api.fda.gov
Vistar Medical Supplies Co., Ltd.	SHENZHEN Guangdong, China	Manufacturer	api.fda.gov
Wellmed Company Limited	Gazipur Sadar, Bangladesh	Manufacturer, Specification developer	api.fda.gov
Wuhan Huaxin Nonwoven Co., Ltd	Wuhan Hubei, China	Contract manufacturer, Exporter to the US	api.fda.gov
Wuhan Lucky Star Non Woven Products Co Ltd	Wuhan Hubei, China	Exporter to the US, Manufacturer, Repackager or relabeler	api.fda.gov
Wuhan Zonsen Medical Products Co., Ltd	Wuhan Hubei, China	Manufacturer	api.fda.gov
Welmed, Inc.	Chicago, IL, United States	Specification developer	api.fda.gov
Xiamen Newclears Daily Products Co.,ltd.	Xiamen Fujian, China	Exporter to the US, Manufacturer	api.fda.gov
Xianning Full Guard Medical Products Co.,ltd	Xianning City Hubei, China	Manufacturer	api.fda.gov
Xiantao Chenguang Protection Commodity Co Ltd	XIANTAO Hubei, China	Contract manufacturer, Manufacturer	api.fda.gov
Xiantao Daoqi Plastic Co., Ltd.	Xiantao Hubei, China	Contract manufacturer, Manufacturer	api.fda.gov
Xiantao Generalcare Protection Products Co.,ltd	Xiantao City Hubei, China	Exporter to the US, Manufacturer	api.fda.gov
Xiantao Kimberly Protective Products Co., Ltd	Xiantao Hubei, China	Manufacturer	api.fda.gov
Xiantao Maosheng Plastic Products Co., Ltd.	XIANTAO CITY Hubei, China	Manufacturer	api.fda.gov
Xiantao Rayxin Medical Products Co., Ltd.	XIANTAO Hubei, China	Contract manufacturer, Manufacturer	api.fda.gov
Xiantao S&J Protective Products Co., Ltd	Xiantao Hubei, China	Exporter to the US, Manufacturer	api.fda.gov
Xiantao Topmed Nonwoven Protective Products Co., Ltd	xiantao Hubei, China	Manufacturer	api.fda.gov
Xiantao TSW Protective Products Co., Ltd.	Xiantao Hubei, China	Manufacturer	api.fda.gov
Xiantao Zhibo Nonwoven Products Co.,ltd	Xiantao City Hubei, China	Exporter to the US, Manufacturer	api.fda.gov
Xiantao Zhongyi Safety & Protection Products Co.,Ltd.	Xiantao City Hubei, China	Manufacturer	api.fda.gov
Yadu Medical (henan) Co., Ltd	Changyuan Henan, China	Manufacturer	api.fda.gov
Yearstar Healthcare Technology Co.,ltd	JIANGYIN Jiangsu, China	Exporter to the US, Manufacturer	api.fda.gov
Zhejiang Anji Huabu Industrial Co., Ltd.	HUZHOU Zhejiang, China	Manufacturer	api.fda.gov

Updated May 5, 1992. 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.