Data / Medical devices / Brush, Scrub, Operating-Room
Brush, Scrub, Operating-Room (GEC): 70 FDA-registered makers in 15 countries
70 establishments in 15 countries are registered with the FDA to make Brush, Scrub, Operating-Room (product code GEC, Class 1, 21 CFR 878.4800). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 37 510(k) clearances under this code, the latest on July 7, 1997, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- GEC
- Device class
- 1
- Regulation
- 878.4800
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| China | 30 |
| United States | 15 |
| India | 5 |
| Pakistan | 4 |
| Germany | 3 |
| Thailand | 2 |
| Vietnam | 2 |
| Canada | 2 |
| Bulgaria | 1 |
| Taiwan | 1 |
| France | 1 |
| Russia | 1 |
| Malaysia | 1 |
| Turkey | 1 |
| Colombia | 1 |
Makers of Brush, Scrub, Operating-Room
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 |
|---|---|---|---|---|---|---|---|---|
| Aegis Lifesciences Private Limited | Ahmedabad Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anhui Medfaith Medical Devices Co., Ltd. | Tianchang Anhui, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anhui Medpurest Medical Technology Co.,ltd | Anqing Anhui, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anqing Kangmingna Packaging Co.,ltd | Anqing Anhui, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apyx Bulgaria Ltd. | Sofia, Bulgaria | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apyx Medical Corporation | Clearwater, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becton Dickinson | Franklin Lakes, NJ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becton Dickinson Infusion Therapy Systems Inc. | Sandy, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioseal | Placentia, CA, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Besmed Health Business Corporation | New Taipei City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carefusion 2200, Inc. | Vernon Hills, IL, United States | Complaint file establishment, Specification developer | 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 Newrise Medical & Hygiene Products Co., Ltd | Changzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cordica Medical, Inc. | Morristown, TN, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Decomicro SAS | Naintre Nouvelle-Aquitaine, France | Contract 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 | |
| Endonest Medical Systems LLP | PALGHAR Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Erchinger AG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foamtec International Co., Ltd. | Sriracha Chon Buri, Thailand | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gcmedica Enterprise Ltd.(wuxi) | WUXI Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gfa Production Inc | Clearwater, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GLX Medical Devices Company Limited | Bien Hoa Dong Nai, Vietnam | Contract manufacturer, Exporter to the US, 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 | |
| Goodwood Medical Care Ltd | Dalian Liaoning, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Aoqun New Materials Co.,Ltd | Guangzhou Guangdong, China | Exporter to the US, 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 | |
| Helmut Zepf Medizintechnik GMBH | SEITINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hive International Pvt Ltd. | Sialkot Punjab, Pakistan | 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 | |
| Inspiration MFG. & Trading Co. | DONGGUAN Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Hanheng Medical Technology Co., Ltd | Changzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu JianYu Health Medical Co., Ltd | Changzhou City Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kazan Medical Instruments Plant Joint Stock Compan | KAZAN Tatarstan, Russia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Labchem Sdn. Bhd | PETALNG JAYA Selangor, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Linhai Deyi Plastic Co., Ltd | Linhai City Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maitland Engineering | South Bend, IN, United States | Contract 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 | |
| Miraclus Orthotech Private Limited | Ahmedabad Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Narang Medical, Ltd. | New Delhi, India | 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 | |
| Phoenix Instruments, Inc. | Lisle, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plasti-Med Plastik Medikal Urunler San. Ve Tic. Ltd. Sti. | Tuzla Istanbul, Turkey | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Poly Medicure Ltd | Jaipur Rajasthan, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Premium Plus (dongguan) Limited | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primed Instruments, Inc. | MISSISSAUGA Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Puli Healthcare (thailand) Co., Ltd. | Bangkok Samut Prakan, Thailand | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qsa Surgical (pvt) Ltd. | SIALKOT Punjab, Pakistan | 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 | |
| RZ Medizintechnik GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SDP Inc. | Saint-Laurent Quebec, Canada | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Since Household Care Co.,ltd | Dongguan City Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgicon Pvt Ltd | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | SUZHOU Jiangsu, China | Contract 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 | |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vygon Colombia S.A. | BARRANQUILLA Atlantico, Colombia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wright Medical Technology, Inc. | Arlington, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wright Medical Technology, Inc. | Arlington, TN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wuhan Zonsen Medical Products Co., Ltd | Wuhan Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Weihai Hongyu Nonwoven Fabric Products Co.,Ltd | Weihai Shandong, 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 | |
| Yangzhou Medline Industry Co., Ltd. | Yangzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yiwu Ruoxuan Garment Co.,ltd | Jinhua Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Anji Huabu Industrial Co., Ltd. | HUZHOU Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Lidesen Medical Instrument Co., Ltd | Hangzhou Zhejiang, China | Contract manufacturer, 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 Qichuang Medical Products Co.,ltd. | Zibo Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 7, 1997. 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.