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Data / Medical devices / Apron, Protective

Apron, Protective (IWO): 64 FDA-registered makers in 11 countries

64 establishments in 11 countries are registered with the FDA to make Apron, Protective (product code IWO, Class 1, 21 CFR 892.6500). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on March 15, 1977, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code
IWO
Device class
1
Regulation
892.6500
Medical specialty
Radiology

Makers by country

CountryMakers
China38
United States14
India4
Pakistan1
Turkey1
Australia1
Germany1
Philippines1
South Korea1
Vietnam1
Canada1

Makers of Apron, Protective

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
Alimed, LLCDedham, MA, United StatesSpecification developer0000api.fda.gov
Anhui Medpurest Medical Technology Co.,ltdAnqing Anhui, ChinaExporter to the US, Manufacturer0000api.fda.gov
Anji Hongde Medical Products Co., Ltd.HUZHOU Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Anji Spenq Industrial Co., Ltd.Huzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Beijing Kelida Medical Equipment Developing Co., LtdBeijing City, ChinaManufacturer0000api.fda.gov
Boen Healthcare Co., Ltd.Suzhou Jiangsu, ChinaExporter to the US, Specification developer0000api.fda.gov
Burlington Medical, LLCNewport News, VA, United StatesManufacturer0010api.fda.gov
Central Surgical Co. Pvt. Ltd.Sialkot Punjab, PakistanManufacturer0000api.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
Ecollink Non-Woven Company LimitedHongkong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Fujian JR Hygiene Products Company LimitedQUANZHOU Fujian, ChinaExporter to the US, Manufacturer0000api.fda.gov
Greens Surgicals Private LimitedVadodara Gujarat, IndiaManufacturer0000api.fda.gov
Hangzhou Alline Plastic Co., Ltd.HANGZHOU Zhejiang, ChinaContract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Hangzhou Queenhe Import & Export Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Hefei Mlush Sanitary Products Co.,ltdHefei Anhui, ChinaManufacturer0000api.fda.gov
Henan Aile Industrial Co., Ltd.zhengzhou Henan, ChinaContract sterilizer, Manufacturer0000api.fda.gov
Hospital Equipment MFG. Co.NOIDA Uttar Pradesh, IndiaManufacturer0000api.fda.gov
Hubei Feiteng Protective Products Co.,ltdXiantao Hubei, ChinaManufacturer0000api.fda.gov
Hubei Qianjiang Kingphar Medical Material Co., LtdQianjiang, Hubei, ChinaExporter to the US, Manufacturer, Repackager or relabeler0000api.fda.gov
Huzhou Junda Industry Co., Ltd.Anji Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S.Konya, TurkeyManufacturer0000api.fda.gov
Infab, LLC.Camarillo, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Imaging Solutions (AU)Park Ridge Queensland, AustraliaContract manufacturer, Manufacturer0000api.fda.gov
Jianyi EnterprisesTIANMEN Hubei, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Kimlead Hygiene Products (hebei) Co.,ltd.Xingtai Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Kiran Medical Systems A Div of Trivitron Healthcare Pvt. LtdNavi Mumbai Maharashtra, IndiaManufacturer0000api.fda.gov
Mavig GMBHMUNICH Bavaria, GermanyManufacturer0000api.fda.gov
Ningbo Greetmed Medical Instruments Co., Ltd.Ningbo Zhejiang, ChinaExporter to the US, Specification developer0000api.fda.gov
Ningbo Yingmed Medical Instruments Co.,ltd.Ningbo Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Ningjin Runboda Medical Protective Products Co., Ltd.Xingtai Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Palmero Healthcare LLCNorthbrook, IL, United StatesManufacturer0000api.fda.gov
Protech Leaded Eyewear, Inc.West Palm Beach, FL, United StatesContract manufacturer, Manufacturer, Specification developer0000api.fda.gov
Quanzhou V-Care Sanitary Products Co.,ltdQuanzhou Fujian, ChinaExporter to the US, Manufacturer0000api.fda.gov
Radprotection Co. Ltd.Lapu-Lapu City Cebu(Province), PhilippinesManufacturer0000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesSpecification developer0000api.fda.gov
RF Design, Inc.Howell, MI, United StatesManufacturer0000api.fda.gov
Rizhao Sanqi Medical & Health Articles Co., LtdRizhao Shandong, ChinaManufacturer0000api.fda.gov
Salus Scientific CorpCharleston, SC, United StatesManufacturer0000api.fda.gov
Shanghai Dochem Industries Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Shielding Intl., Inc.Madras, OR, United StatesManufacturer0000api.fda.gov
Sungkwang Meditech., Co., LtdYangju-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Sanqi (Vietnam) New Material Co., LtdTan Phuoc 3 Commune Dong Thap, VietnamManufacturer0000api.fda.gov
Shanghai Joy Crown Industry Co., LtdPu Dong New Area Shanghai, ChinaContract manufacturer0000api.fda.gov
Suzhou Colour-way New Material Co., Ltd.Suzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Techno-Aide, Inc.Whites Creek, TN, United StatesManufacturer0000api.fda.gov
TF New Material Sci And Tec Co.,ltdHuainan Anhui, ChinaManufacturer0000api.fda.gov
Tissue Protective Products Co., Ltdtianmen Hubei, ChinaManufacturer0000api.fda.gov
Trivitron Imaging Solutions IncScottsboro, AL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Two One Two New York, Inc.Edgewood, NY, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Ultraray Group Inc.Oakville Ontario, CanadaManufacturer0000api.fda.gov
Uniray Medical LLPNavi Mumbai Maharashtra, IndiaManufacturer0000api.fda.gov
V&Q Manufacturing CorporationXiantao Hubei, ChinaManufacturer0000api.fda.gov
Wolf X-Ray CorpBattleboro, NC, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Worldwide Innovations & Technologies, Inc.Lenexa, KS, United StatesManufacturer0000api.fda.gov
Wuhan Lucky Star Non Woven Products Co LtdWuhan Hubei, ChinaExporter to the US, Manufacturer, Repackager or relabeler0000api.fda.gov
Wuhan Youfu International Trade Co.,ltdWuhan Hubei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Xiantao Junlong Protective Products Co.,ltdXiantao Hubei, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Xiantao S&J Protective Products Co., LtdXiantao Hubei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Yadu Medical (henan) Co., LtdChangyuan Henan, ChinaManufacturer0000api.fda.gov
Yearstar Healthcare Technology Co.,ltdJIANGYIN Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zhejiang Lidesen Medical Instrument Co., LtdHangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zhejiang Mediunion Healthcare Group Co.,ltdNingbo Zhejiang, ChinaManufacturer0000api.fda.gov
Zibo Qichuang Medical Products Co.,ltd.Zibo Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov

Updated March 15, 1977. 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.