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Data / Medical devices / Radiographic Protective Glove

Radiographic Protective Glove (IWP): 46 FDA-registered makers in 8 countries

46 establishments in 8 countries are registered with the FDA to make Radiographic Protective Glove (product code IWP, Class 1, 21 CFR 892.6500). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 5 510(k) clearances under this code, the latest on May 29, 1992, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
IWP
Device class
1
Regulation
892.6500
Medical specialty
Radiology

Makers by country

CountryMakers
China24
United States10
Vietnam3
Malaysia3
India3
Costa Rica1
Ireland1
Italy1

Makers of Radiographic Protective Glove

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
Infab, LLC.Camarillo, CA, United StatesManufacturer1May 1, 1990000api.fda.gov
Aadco Medical, Inc.Randolph, VT, United StatesManufacturer0000api.fda.gov
Actlife Technology Co., Ltd - Thanh Hoa BranchTrung Chinh Commune Thanh Hoa, VietnamManufacturer0000api.fda.gov
Ansell Healthcare Products LLCReno, NV, United StatesSpecification developer0000api.fda.gov
Ansell N.P. Sdn. Bhd.Melaka, MalaysiaExporter to the US, Manufacturer, Repackager or relabeler0000api.fda.gov
Ashtel Studios, Inc.Ontario, CA, United StatesSpecification developer0000api.fda.gov
Boston Scientific CorporationLa Aurora Heredia, Costa RicaSpecification developer0000api.fda.gov
Boston Scientific CorporationSpencer, IN, United StatesManufacturer0000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer0000api.fda.gov
Boston Scientific LimitedGALWAY Galway(County), IrelandManufacturer0000api.fda.gov
Cangzhou Jinkuijia Medical Devices Co., Ltd.Cangzhou Hebei, ChinaManufacturer0000api.fda.gov
Cangzhou Youmeiyou Rubber Products Co., Ltd.Chang zhou Hebei, 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
Dongguan Luda Industrial Co., LtdDongguan Guangdong, ChinaManufacturer0000api.fda.gov
Dongyang City Yonoel Outdoor Products Co.,ltdDongyang Zhejiang, ChinaExporter to the US, Manufacturer, Repackager or relabeler0000api.fda.gov
Dongguan City Ruimi Gift Products Co LtdDongguan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Dongguan Sheng Yan Industrial Co., Ltd.DongGuan Guangdong, ChinaManufacturer0000api.fda.gov
Emerson & Co. S.R.L.GENOA Genova, ItalyManufacturer0000api.fda.gov
F & L Medical Products LLCVandergrift, PA, United StatesManufacturer0000api.fda.gov
Guangdong Comfort Medical Products Co., Ltd.Jiangmen Guangdong, ChinaManufacturer0000api.fda.gov
Guilin HBM Health Protections, Inc.Guilin Guangxi, ChinaManufacturer0000api.fda.gov
H&K International Trade Limited (china)jinhua Zhejiang, ChinaManufacturer0000api.fda.gov
Hefei Anan Trade Development Co. Ltd.Hefei Anhui, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hengshui Gangsheng Medical Instruments Co., LtdHengshui Hebei, ChinaManufacturer0000api.fda.gov
Huzhou Universal Glove Company LimitedHuzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hynaut Health Technology Co., LTD.Qingdao Shandong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Ineo Tech Sdn BhdBandar Cassia Pulau Pinang, MalaysiaContract manufacturer, Manufacturer0000api.fda.gov
Jiangsu Hanheng Medical Technology Co., LtdChangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Kiran Medical Systems A Div of Trivitron Healthcare Pvt. LtdNavi Mumbai Maharashtra, IndiaManufacturer0000api.fda.gov
MB Regentox Vietnam Trading Service Company LimitedHo Chi Minh City, VietnamForeign private label distributor, Manufacturer0000api.fda.gov
Ningbo Chibanda Imp &exp Co, LtdNingbo Zhejiang, ChinaManufacturer0000api.fda.gov
Ningbo Tianbo First Aid Product Co., Ltd.Ningbo Zhejiang, ChinaManufacturer0000api.fda.gov
Protech Leaded Eyewear, Inc.West Palm Beach, FL, United StatesSpecification developer0000api.fda.gov
RFB GlovesNOIDA Uttar Pradesh, IndiaManufacturer0000api.fda.gov
Shandong Jinlai Huanhai Medical Technology Co.,ltdYantai Shandong, ChinaManufacturer0000api.fda.gov
Shielding Intl., Inc.Madras, OR, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Stevimed Medical Joint Stock CompanyCan Giuoc Commune Tay Ninh, VietnamManufacturer0000api.fda.gov
Suzhou Colour-way New Material Co., Ltd.Suzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Uniray Medical LLPNavi Mumbai Maharashtra, IndiaManufacturer0000api.fda.gov
Wolf X-Ray CorpBattleboro, NC, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
WRP Asia Pacific Sdn. Bhd.SALAK TINGGI, SEPANG Selangor, MalaysiaContract manufacturer, Manufacturer0000api.fda.gov
Yancheng Trancom First Aid Supplies Industrial Co., LtdYangcheng Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Yangzhou Feiyali Sporting Goods Co.ltdYangzhou Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Yiwu Kebon Healthcare Co., Ltd.Yiwu Zhejiang, ChinaExporter to the US, Manufacturer, Repackager or relabeler0000api.fda.gov
Yiwu Ori-Power Medtech Co., Ltd.YIWU Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zhejiang Mediunion Healthcare Group Co.,ltdNingbo Zhejiang, ChinaManufacturer0000api.fda.gov

Updated May 29, 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.