Data / Medical devices / Gown, Examination
Gown, Examination (FME): 189 FDA-registered makers in 20 countries
189 establishments in 20 countries are registered with the FDA to make Gown, Examination (product code FME, Class 1, 21 CFR 880.6265). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 5 510(k) clearances under this code, the latest on February 19, 1988, and lists 1 recall event (0 Class I). 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.
- Product code
- FME
- Device class
- 1
- Regulation
- 880.6265
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| China | 86 |
| United States | 35 |
| Pakistan | 13 |
| Vietnam | 12 |
| India | 9 |
| Mexico | 6 |
| Cambodia | 5 |
| Bangladesh | 4 |
| South Korea | 3 |
| Canada | 3 |
| Myanmar | 2 |
| Thailand | 2 |
| El Salvador | 2 |
| Taiwan | 1 |
| Hong Kong | 1 |
| Sri Lanka | 1 |
| Laos | 1 |
| Peru | 1 |
| Kenya | 1 |
| Haiti | 1 |
Makers of Gown, Examination
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 | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Adroit Medical Systems, Inc. | Loudon, TN, United States | 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 | |
| Allcare, Inc. | St Charles, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alphaprotech, Inc. | Nogales, AZ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Am Nonwovens | Madurai Tamil Nadu, India | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amaryllis Healthcare Pvt. Ltd | Bangalore Karnataka, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| American Dawn Inc. | Compton, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ammar Apparel Ii S. De R.L De C.V. | CALKINI Campeche, Mexico | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Andersen Industries Co., Ltd. | Angsnoul District Kandal, Cambodia | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Angeline Group Ltd. | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anhui JM Healthcare Products Co.,ltd. | Shouxian Anhui, China | 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 | |
| Anyang Sukangning Medical Products Co., Ltd | Anyang Henan, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arrow Medsource Group Limited | Hongkong, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AZTA Textile Solutions (Pvt) Ltd | Karachi East Sindh, Pakistan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arshad Corporation (Pvt) Ltd | Faisalabad Punjab, Pakistan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avanos Medical, Inc. | Alpharetta, GA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beximco Ppe Limited | Dhaka Dhaka(Division), Bangladesh | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BH Medical Products Co., Ltd | Changzhou City Jiangsu, China | Contract manufacturer, 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 | |
| Blue Sail (hong Kong) Trading Limited | Harbour, Hong Kong | Exporter to the US, Specification developer | 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 | |
| Border Opportunity Saver Systems, Inc. | Del Rio, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C K Hygiene Pvt Ltd | Hyderabad Telangana, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Casco Manufacturing Solutions, Inc. | Cincinnati, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Care-De Sanitary Material Co., Ltd | Changzhou Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Holymed Products Co., Ltd | CHANGZHOU Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Hongtai Paper Film Co., Ltd | Changzhou Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chengdu Ruinuo Meijer Medical Instrument Co., Ltd. | Chengdu Sichuan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cobes Industries (bago) Company Limited | Bago, Myanmar | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cobes Industries (bii) Company Limited | Bago Region, Myanmar | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Copious (cambodia) International Inc. | Takeo, Cambodia | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Copious Intl., Inc. | Heyuan, Guangdong Province, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Core Products International Inc | Chetek, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Crown Name Disposable Hygiene Products Fty. Ltd. | Wuhan Hubei, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Daemyung Chemical Co., Ltd (vietnam) | An Phuoc Commune Dong Nai, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dasol International Ltd. | Siheung-Si Gyeonggi, South Korea | 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 | |
| Dukal LLC | Ronkonkoma, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ecollink Non-Woven Company Limited | Hongkong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Emerald Nonwovens Intl. Co., Ltd. | Phetchaburi, Thailand | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Encompass Group, LLC. | McDonough, GA, United States | Complaint file establishment, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Fabrication Ent., Inc. | Elmsford, NY, United States | 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 | |
| Foshan Hongfeng Co.,ltd | Foshan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fullstar Non-Woven Products Co.,ltd. | Xiantao City Hubei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Feroze1888 Mills | KARACHI Sindh, Pakistan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fujian Dashan Paper CO LTD | QUANZHOU Fujian, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GD Group USA Company | Bartlett, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| George Courey Inc | Montreal Quebec, Canada | Complaint file establishment, Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Fuzelong Hygiene Material Co.,ltd. | Guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Harley Commodity Company Limited | Guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Goodwood Medical Care Ltd | Dalian Liaoning, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Four E's Scientific Co., Ltd. | GUANGZHOU Guangdong, China | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gushi priMED Medical Products Manufacturing Co., Ltd. | Gushi County Henan, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hameco Hy Co., Ltd | Hung Yen Province, Vietnam | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hanh Minh Manufacturing Trading Company Limited | Bien Hoa Dong Nai, Vietnam | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haody Medical Technology (vietnam) Company Limited | Ho Chi Minh City, Vietnam | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Harmony Plastics Private Ltd | Surat Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hartford Healthcare | Hartford, CT, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hefei Jingcheng Plastic Products Co. Ltd | Hefei Anhui, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hindustan Apparel Industries | Hyderabad Telangana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HK Surgical, Inc. | San Clemente, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Honghu Danielle Sanitary Material Co., Ltd. | Honghu City Hubei, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HPK Industries | Frankfort, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei Deming Healthcare Products Co.,ltd. | Xiantao Hubei, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei Deming Healthcare Products Co.,ltd.first Branch | Xiantao City Hubei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei Feiteng Protective Products Co.,ltd | Xiantao Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei Fumo Paper Products Co. Ltd | Wuhan Hubei, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei Huanfu Plastic Products Co., Ltd | HANCHUAN CITY Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei Qianjiang Kingphar Medical Material Co., Ltd | Qianjiang, Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei Weikang Protective Products Co.ltd | XIANTAO Hubei, 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 | |
| Halyard North Carolina, LLC | Linwood, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Harmony Plastics P. Ltd. | Udaipur Rajasthan, India | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heaven Healthcare Co., Ltd. | Shaoxing Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebei Ruinuo Medical Instrument Co Ltd | Shijiazhuang Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hefei Xingcheng Sanitary Products CO.,LTD | Hefei Anhui, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heuer International (A division of GST Corporation Limited) | NOIDA Uttar Pradesh, India | Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei Haixin Protective Products Group Co.,Ltd | Songzi City Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei Yiye Plastics Co. LTD | Tianmen Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Icat S.A. De C.V. | San Salvador, El Salvador | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intco Medical Technology Viet Nam Company Limited | Dong Mai Ward Quang Ninh, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| International Textile Limited | Karachi Sindh, Pakistan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrias Apson S.A de C.V | AGUA PRIETA Sonora, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Hanfang Textile Technology Co., Ltd | Xuzhou City Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Medplus Non-Woven Manufacturer Co.,ltd. | Siyang Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiehong Medical Products(bangladesh) Co.ltd | Chattogram Chittagong(Division), Bangladesh | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiehong Nonwoven Products(bd) Co.,ltd | Chattogram Chittagong(District), Bangladesh | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jingzhou Haixin Green Cross Medical Products Co.,ltd | Jingzhou Hubei, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Guangda Medical Material Group Co., Ltd. | Haian Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangyin Huaying Light Industrial Products Co., LTD | Jiangyin Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Liberty Mills, Ltd. | KARACHI Sindh, Pakistan | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lingxian Dongsheng Textile Co., Ltd. | Dezhou Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lucky Impex | Karachi Sindh, Pakistan | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lucky Textile Mills Limited | KARACHI Sindh, Pakistan | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| La Ada de Acuna | CIUDAD DE ACUNA Coahuila, Mexico | 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 | |
| Lianyungang Bronson Non-woven Products Co., Ltd. | LIANYUNGANG Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Little Rapids Corporation | Green Bay, WI, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Manufacturas Ke | Nogales Sonora, Mexico | Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maquiladora De Coahuila S De RL De CV | CUIDAD ACUNA Coahuila, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Master & Frank (cambodia) Co., Ltd. | Angsnoul Kandal, Cambodia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MB Regentox Vietnam Trading Service Company Limited | Ho Chi Minh City, Vietnam | Foreign private label distributor, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MDK (shanghai) Medical Packing Co., Ltd | Shanghai, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtecs (cambodia) Corp. Limited | Srok Kampong Siem Kampong Cham, Cambodia | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Minra Garments (pvt) Ltd | Puttlam North Western, Sri Lanka | Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mip Usa | Bolingbrook, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mip, Inc. | ANJOU Quebec, Canada | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mustaqim Dyeing & Printing Industries (pvt.) Ltd. | Karachi Sindh, Pakistan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medegen Medical Products | Gallaway, TN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningjin Runboda Medical Protective Products Co., Ltd. | Xingtai Hebei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nucare LLC | Montclair, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nurses Choice Corp. | Wilmington, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| O&M Halyard, Inc. | Alpharetta, GA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Operating Theatre Medical Bangladesh Company Limited | Kaliakair Gazipur, Bangladesh | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Patientstyle Medical LLC | San Leandro, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prestige Ameritech | North Richland Hills, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PRIMED Laos Medical Products Manufacturing Sole Co., Ltd. | Vientiane Capital Viangchan(Prefecture), Laos | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primed Medical Products Inc. | Edmonton Alberta, Canada | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Picard Healthcare Technology (Dongguan) Co. Ltd | Dongguan Guangdong, China | 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 | |
| Quang Nam Medical Devices Factory Branch Of Danameco Medical Joint Stock Corporation | Dien Ban Bac Ward Da Nang, Vietnam | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| R & G Seguridad E Higiene Industrial S.A.C. | VENTANILLA Lima(Province), Peru | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ready Set Import | Beverly Hills, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Reolite Company Inc. | Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rugao Smiling Healthcare Teconolgy Developent Co., Ltd | Rugao Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Samaritan Textile (cambodia) Co., Ltd. | Phnom Penh, Cambodia | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sanmu (vietnam) Protective Products Co., Ltd | Duc Hoa Commune Tay Ninh, Vietnam | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sejong Healthcare Co., Ltd. | Paju Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shah Safari | Seattle, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Hengfa Hygienic Products Co.,ltd. | Linqing City,liaocheng City, Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shunde Lucas Industries | Foshan City Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Silver Plus Corp. | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Speedway | India Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Standard Textile Co., Inc. | Cincinnati, OH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Star Fabrics | Faisalabad Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stavian Chemical Joint Stock Company | Nhu Quynh Commune Hung Yen, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stevimed Medical Joint Stock Company | Can Giuoc Commune Tay Ninh, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Superior Group Of Companies, Inc. | Saint Petersburg, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Joy Crown Industry Co., Ltd | Pu Dong New Area Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Simba Apparel EPZ LTD | Mombasa, Kenya | 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 | |
| Small Beginnings Inc. | Hesperia, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sterling Medical Products | Prophetstown, IL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sultex Industries | karachi Sindh, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Superior Sourcing | Quanaminthe Nord-Est, Haiti | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Dukangning Medical Products Co., Ltd | Suzhou Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Thai Hospital Products Co., Ltd. | Muang Samut Prakan, Thailand | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Theni Guru Krishna Textile Mills (P) Ltd. | Theni Tamil Nadu, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tidi Products, LLC | Neenah, WI, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Topwin(hubei) Medical Products Manufacturer | Suizhou Hubei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Transparent Supply Solutions Ltd. | Dover, DE, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| U.S. Pacific Nonwovens Technology (Dongguan) Ltd | Dongguan City Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| United towel Exporters | Karachi Sindh, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| V&Q Manufacturing Corporation | Xiantao Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vien Phat Import Export Service Trading Joint Stock Company | Ben Thanh Ward Ho Chi Minh, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| VT Production Medical Materials Production Corporation | Can Giuoc Commune Tay Ninh, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vidales Larranaga SA de CV | Ahuachapan, El Salvador | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wear Tex S. De R.L. De C.V. | Torreon Coahuila, Mexico | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Weihai Dishang Medical Technology Co.,ltd | Weihai Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wuhan Huaxin Nonwoven Co., Ltd | Wuhan Hubei, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wuhan Lucky Star Non Woven Products Co Ltd | Wuhan Hubei, China | Exporter to the US, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wuhan Zonsen Medical Products Co., Ltd | Wuhan Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wellmed Dental Medical Supply Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Welmed, Inc. | Chicago, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Ortocare Sports Health Co.,ltd. | Xiamen Free Trade Zone Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xian Tao Crosscare Protective Products Co.,ltd | Xian Tao Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiantao City Songqing Plastic Products Co., Ltd. | Xiantao Hubei, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiantao Hooray Protective Products Co.,ltd | Xiantao City Hubei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiantao Junhui Plastic Products Co.,ltd. | Xiantao Hubei, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiantao Rayxin Medical Products Co., Ltd. | XIANTAO Hubei, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiantao S&J Protective Products Co., Ltd | Xiantao Hubei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| XIANTAO XINFA PLASTIC PRODUCTS Co. LTD. | Xiantao City Hubei, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiantao Xingrong Protective Products Co., Ltd. | Xiantao Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiantao Zhongyi Safety & Protection Products Co.,Ltd. | Xiantao City Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yadu Medical (henan) Co., Ltd | Changyuan Henan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yancheng Jingwei Chemicals Co., Ltd | Yancheng Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhou Weideli Trading Co., Ltd. | Yangzhou Jiangsu, China | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yunus Textile Mills Limited | Karachi Sindh, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zaozhuang Huayang Hongdan Clothing Co., Ltd. | Zhaozhang Jiangsu, China | Contract 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 | |
| Zibo Dayang Flame Retardant Textile Co.,ltd | Zibo Shandong, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zibo Qichuang Medical Products Co.,ltd. | Zibo Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zibo Intco Medical Products Company Limited | Zibo Shandong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| priMED Jiujiang Medical Products Manufacturing Co., Ltd | Jiujiang Jiangxi, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 19, 1988. 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.