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Data / Medical devices / Shoe And Shoe Cover, Conductive

Shoe And Shoe Cover, Conductive (BWP): 38 FDA-registered makers in 8 countries

38 establishments in 8 countries are registered with the FDA to make Shoe And Shoe Cover, Conductive (product code BWP, 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 3 510(k) clearances under this code, the latest on June 23, 1988, and lists 0 recall events (0 Class I). FDA data exported November 2, 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
BWP
Device class
1
Regulation
878.4040
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
China25
United States4
India3
Mexico2
Cambodia1
Sri Lanka1
Vietnam1
Thailand1

Makers of Shoe And Shoe Cover, Conductive

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Aimmax Medical Products Co.,ltd.Shiyan Hubei, ChinaContract manufacturer0000api.fda.gov
Alphaprotech, Inc.Nogales, AZ, United StatesSpecification developer0000api.fda.gov
Arrow Medsource Group LimitedHongkong, ChinaExporter to the US, Specification developer0000api.fda.gov
Biomed Plastics Co.Taicang, Jiangsu, ChinaManufacturer0000api.fda.gov
Boen Healthcare Co., Ltd.Suzhou Jiangsu, ChinaExporter to the US, Specification developer0000api.fda.gov
Cellucap Manufacturing Co.Phila, PA, United StatesSpecification developer0000api.fda.gov
Changzhou Holymed Products Co., LtdCHANGZHOU Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Dalian Rongbang Medical Healthy Devices Co LtdDalian Liaoning, ChinaManufacturer0000api.fda.gov
Debo Medical Technology (shijiazhuang) Co., Ltd.Shijiazhuang Hebei, ChinaContract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Ecollink Non-Woven Company LimitedHongkong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Fomed Industries IncQian Jiang Hubei, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Hangzhou Alline Plastic Co., Ltd.HANGZHOU Zhejiang, ChinaContract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Hangzhou Jincheng Medical Supplies Manufacture Co., Ltd.Hangzhou Zhejiang, ChinaSpecification developer0000api.fda.gov
Harmony Plastics Private LtdSurat Gujarat, IndiaManufacturer0000api.fda.gov
Hubei Feiteng Protective Products Co.,ltdXiantao Hubei, ChinaManufacturer0000api.fda.gov
Hubei Huanfu Plastic Products Co., LtdHANCHUAN CITY Hubei, ChinaManufacturer0000api.fda.gov
Hubei Weikang Protective Products Co.ltdXIANTAO Hubei, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Harmony Plastics P. Ltd.Udaipur Rajasthan, IndiaContract manufacturer, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Jiangsu Hanfang Textile Technology Co., LtdXuzhou City Jiangsu, ChinaContract manufacturer0000api.fda.gov
Jiujiang Huada Medical Dressing Co., Ltd.JIUJIANG Jiangxi, ChinaManufacturer0000api.fda.gov
La Ada de AcunaCIUDAD DE ACUNA Coahuila, MexicoManufacturer0000api.fda.gov
Manufacturas KeNogales Sonora, MexicoContract manufacturer, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Medtecs (cambodia) Corp. LimitedSrok Kampong Siem Kampong Cham, CambodiaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Minra Garments (pvt) LtdPuttlam North Western, Sri LankaContract manufacturer, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Nanjing J SUN Healthcare Co.,LtdNanjing Jiangsu, ChinaManufacturer0000api.fda.gov
O&M Halyard, Inc.Alpharetta, GA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Quang Nam Medical Devices Factory Branch Of Danameco Medical Joint Stock CorporationDien Ban Bac Ward Da Nang, VietnamContract manufacturer, Manufacturer0000api.fda.gov
Shandong Zhushi Pharmaceutical Group Co., LtdHeze Shandong, ChinaManufacturer0000api.fda.gov
Shanghai Alwings Medical Instrument Co.,ltd.Shanghai, ChinaManufacturer0000api.fda.gov
SpeedwayIndia Delhi, IndiaManufacturer0000api.fda.gov
Thai Hospital Products Co., Ltd.BANGPUD, PAKKRED, Nonthaburi, ThailandContract manufacturer, Manufacturer0000api.fda.gov
Tiger Medical GroupShanghai, ChinaExporter to the US, Specification developer0000api.fda.gov
Transparent Supply Solutions Ltd.Dover, DE, United StatesSpecification developer0000api.fda.gov
V&Q Manufacturing CorporationXiantao Hubei, ChinaManufacturer0000api.fda.gov
Wuhan Huaxin Nonwoven Co., LtdWuhan Hubei, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Xianning Full Guard Medical Products Co.,ltdXianning City Hubei, ChinaManufacturer0000api.fda.gov
Yearstar Healthcare Technology Co.,ltdJIANGYIN Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
ZOGEAR Medical Co., Ltd.Yizheng Jiangsu, ChinaManufacturer0000api.fda.gov

Updated June 23, 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.