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Data / Medical devices / Shield, Protective, Personnel

Shield, Protective, Personnel (KPY): 160 FDA-registered makers in 19 countries

160 establishments in 19 countries are registered with the FDA to make Shield, Protective, Personnel (product code KPY, Class 1, 21 CFR 892.6500). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 25 510(k) clearances under this code, the latest on June 24, 2011, and lists 2 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
KPY
Device class
1
Regulation
892.6500
Medical specialty
Radiology

Makers by country

CountryMakers
China68
United States53
Canada8
India6
Taiwan4
Vietnam3
Malaysia3
Germany2
Mexico2
Thailand2
Italy1
Australia1
United Kingdom1
France1
Dominican Republic1
Cambodia1
Philippines1
Sweden1
Peru1

Makers of Shield, Protective, Personnel

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 StatesManufacturer2May 1, 1990000api.fda.gov
BLOXR Solutions LLCSalt Lake City, UT, United StatesManufacturer1June 24, 2011000api.fda.gov
Aadco Medical, Inc.Randolph, VT, United StatesManufacturer0000api.fda.gov
Alimed, LLCDedham, MA, United StatesSpecification developer0000api.fda.gov
An Lanh Investment And Trading Company LimitedThanh Nam Ward Ninh Binh, VietnamContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Angiosystems, Inc.Ducktown, TN, United StatesManufacturer0000api.fda.gov
Anhui Ares Medical Technology Co.,ltd.Tianchang Anhui, ChinaManufacturer0000api.fda.gov
Anhui Medpurest Medical Technology Co.,ltdAnqing Anhui, ChinaExporter to the US, Manufacturer0000api.fda.gov
Anji Hengfeng Sanitary Material Co., Ltd.Anji Zhejiang, ChinaForeign private label distributor, Manufacturer0000api.fda.gov
Anji Huifeng Surgical Dressings Co., Ltd.ANJI COUNTY Zhejiang, ChinaComplaint file establishment, Contract manufacturer, Contract sterilizer, Exporter to the US, Foreign private label distributor, Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor, Specification developer0000api.fda.gov
Anji Spenq Industrial Co., Ltd.Huzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Anping Guardian Medical Equipment Co.,ltdHengshui Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Armery Medical Technologies Inc.London Ontario, CanadaContract manufacturer, Specification developer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Anholt Technologies Inc.Avondale, PA, United StatesManufacturer0000api.fda.gov
Anhui Dajiang Medical Products Co.,Ltd.chuzhou Anhui, ChinaManufacturer0000api.fda.gov
Barrier Technologies, LLCDavie, FL, United StatesManufacturer0000api.fda.gov
Beijing Kelida Medical Equipment Developing Co., LtdBeijing City, ChinaManufacturer0000api.fda.gov
Blessing Cathay CorporationNew Taipei City, TaiwanManufacturer0000api.fda.gov
Boston Scientific CorporationMaple Grove, MN, United StatesSpecification developer0000api.fda.gov
Burlington Medical, LLCNewport News, VA, United StatesManufacturer0000api.fda.gov
BWXT Medical Ltd.OTTAWA Ontario, CanadaContract manufacturer0000api.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
Chamfond Biotech Co., Ltd.Nanjing Jiangsu, ChinaManufacturer0000api.fda.gov
Cheng Yi Optical (xiamen) Co., Ltd.Xiamen Fujian, ChinaExporter to the US, Manufacturer0000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer0000api.fda.gov
Dang Phi Industrial And Trading Company LimitedYen Phong District Bac Ninh, VietnamExporter to the US, Manufacturer0000api.fda.gov
Danyang New Hope Medical Equipment Co., LtdDanyang Jiangsu, 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
Diamond Mark International Co., Ltd.Taipei, TaiwanManufacturer0000api.fda.gov
Egg Medical, Inc.Roseville, MN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Emerson & Co. S.R.L.GENOA Genova, ItalyManufacturer0000api.fda.gov
Exact Medical Manufacturing, Inc.Changzhou Jiangsu, ChinaComplaint file establishment, Reprocessor0000api.fda.gov
Exact Medical Manufacturing, Inc.Changzhou Jiangsu, ChinaComplaint file establishment, Reprocessor0000api.fda.gov
F & L Medical Products LLCVandergrift, PA, United StatesManufacturer0000api.fda.gov
FIRSTAR HEALTHCARE Company Limited (Guangzhou)Guangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Fluke BiomedicalEverett, WA, United StatesManufacturer0000api.fda.gov
Foresight OpticalXIAMEN Fujian, ChinaExporter to the US, Manufacturer0000api.fda.gov
Foresight Optical Ltd.Tainan, TaiwanExporter to the US, Manufacturer0000api.fda.gov
GT Medical Technologies, IncTempe, AZ, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Guangzhou Newlife Magnetics Co., Ltd.Guangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Guangzhou Nuoning Medical Supplies Co.,ltdGuangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Guangzhou Xunqi Glasses FactoryGuangzhou Guangdong, ChinaExporter to the US, Manufacturer, Remanufacturer0000api.fda.gov
Gushi priMED Medical Products Manufacturing Co., Ltd.Gushi County Henan, ChinaContract manufacturer0000api.fda.gov
HANGZHOU TUOPUSI MEDICAL PRODUCTS Co. LtdHangzhou City Zhejiang, ChinaManufacturer0000api.fda.gov
Hebumedical GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Hefei Anan Trade Development Co. Ltd.Hefei Anhui, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hefei Mlush Sanitary Products Co.,ltdHefei Anhui, ChinaManufacturer0000api.fda.gov
Henan Joinkona Medical Products Stock Co.,ltdPingdingshan Henan, ChinaContract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor0000api.fda.gov
Honghu Danielle Sanitary Material Co., Ltd.Honghu City Hubei, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Huanghua DK Dental Co., LtdHuangHua Hebei, ChinaManufacturer0000api.fda.gov
Huanghua Promisee Dental Co., LtdHuanghua Hebei, ChinaManufacturer0000api.fda.gov
Hubei Huanfu Plastic Products Co., LtdHANCHUAN CITY Hubei, ChinaManufacturer0000api.fda.gov
Huestis Machine Corp.Bristol, RI, United StatesManufacturer0000api.fda.gov
Huzhou Junda Industry Co., Ltd.Anji Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Hynaut Health Technology Co., LTD.Qingdao Shandong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Innovative Material & Devices, Inc.Wuxi Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Instrumed SurgicalMississauga Ontario, CanadaManufacturer0000api.fda.gov
Intec Industries, Inc.Birmingham, AL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Imaging Solutions (AU)Park Ridge Queensland, AustraliaContract manufacturer, Manufacturer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
International Manufacturing Solutions OperacionesCd. Juarez Chihuahua, MexicoManufacturer0000api.fda.gov
Jiangsu Hanheng Medical Technology Co., LtdChangzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
K-One Meditech Sdn. Bhd.Sekinchan Selangor, MalaysiaContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
K-One MediTech Sdn. BhdIpoh Perak, MalaysiaContract manufacturer, Repackager or relabeler0000api.fda.gov
Kenex (electro-Medical) Ltd.HARLOW Essex, United KingdomManufacturer0000api.fda.gov
Kiran Medical Systems A Div of Trivitron Healthcare Pvt. LtdNavi Mumbai Maharashtra, IndiaManufacturer0000api.fda.gov
Lemer Pax AmericaMontreal Quebec, CanadaContract manufacturer, Manufacturer0000api.fda.gov
Lemer-PaxCarquefou Loire-Atlantique, FranceContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Lords Mark Industries Ltd.Daman and Diu Dadra and Nagar Haveli, IndiaManufacturer0000api.fda.gov
Madison Polymeric EngineeringBranford, CT, United StatesManufacturer0000api.fda.gov
Marco Optical (thailand) Company LimitedBan Bueng Chon Buri, ThailandContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Mark EnterprisesNashik Maharashtra, IndiaManufacturer0000api.fda.gov
Marken Healthtech LimitedNASHIK Maharashtra, IndiaManufacturer0000api.fda.gov
Mavig GMBHMUNICH Bavaria, GermanyManufacturer0000api.fda.gov
Medtec LLCOrange City, IA, United StatesManufacturer0000api.fda.gov
Microtek Dominicana, S.A.S.La Romana, Dominican RepublicManufacturer0000api.fda.gov
Mirion Technologies (capintec), IncFlorham Park, NJ, United StatesManufacturer0000api.fda.gov
Molded Products Inc.Harlan, IA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Magicare Tech CorpOntario, CA, United StatesManufacturer0000api.fda.gov
Microtek Medical LLCEagan, MN, United StatesSpecification developer0000api.fda.gov
Microtek Medical LLCNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Microtek Medical LLCAlpharetta, GA, United StatesSpecification developer0000api.fda.gov
Nam Duong Personal Protective Equipment Manufacturing Joint Stock CompanyDuy Tien Township Ha Nam, VietnamContract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Nanning Tecbod Biological Technology Co.,ltdNanning Guangxi, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Narang Medical, Ltd.New Delhi, IndiaManufacturer0000api.fda.gov
Philips Oral Healthcare, LLCBothell, WA, United StatesSpecification developer0000api.fda.gov
Plenoptika, Inc.Cambridge, MA, United StatesSpecification developer0000api.fda.gov
Prestige AmeritechNorth Richland Hills, TX, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Primed Liyang Medical Products Manufacturing Co., Ltd.Liyang Jiangsu, ChinaContract manufacturer0000api.fda.gov
Primed Medical Products Inc.Edmonton Alberta, CanadaSpecification developer0000api.fda.gov
Paneffort (cambodia) Garment Co., Ltd.Pot Sar Ward, Bati District Takeo, CambodiaManufacturer0000api.fda.gov
Qinhuangdao Taizhi Medical Technology Co., LtdQinhuangdao Hebei, ChinaManufacturer0000api.fda.gov
Qlrad IncMiami, FL, United StatesSpecification developer0000api.fda.gov
Radiation Products Design, Inc.Albertville, MN, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Radium IncorporatedWaynesboro, VA, United StatesManufacturer0000api.fda.gov
Radprotection Co. Ltd.Lapu-Lapu City Cebu(Province), PhilippinesManufacturer0000api.fda.gov
Radux Devices IncFridley, MN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
RAMPART IC, IncBirmingham, AL, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
RAMPART IC, IncVestavia, AL, United StatesManufacturer, Specification developer0000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesSpecification developer0000api.fda.gov
Reina ImagingCrystal Lake, IL, United StatesManufacturer0000api.fda.gov
Salus Scientific CorpCharleston, SC, United StatesManufacturer0000api.fda.gov
Shielding Intl., Inc.Madras, OR, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Sina-Sterilgamma Sdn BhdPelabuhan Klang Selangor, MalaysiaManufacturer0000api.fda.gov
Sirtex Medical Inc.Woburn, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
South West Exposures (2566031 Ont Inc.)Toronto Ontario, CanadaContract manufacturer, Manufacturer, Specification developer0000api.fda.gov
Standard Imaging, Inc.Middleton, WI, United StatesManufacturer0000api.fda.gov
SW Technologies Inc.Union City, CA, United StatesManufacturer0000api.fda.gov
Shanghai Caremate Medical Device Co. LtdShanghai, ChinaContract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer0000api.fda.gov
Shanghai Joy Crown Industry Co., LtdPu Dong New Area Shanghai, ChinaContract manufacturer0000api.fda.gov
Shenzhen Crystal-Star Tech Co., Ltd.Shenzhen City Guangdong, ChinaManufacturer0000api.fda.gov
Skytech Electronics (HK) LimitedTsim Sha Tsui Hong Kong, ChinaContract manufacturer0000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesManufacturer0000api.fda.gov
Suzhou Colour-way New Material Co., Ltd.Suzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Taijia Medical Electronics (shenzhen) Co.,ltdShenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
Taizhou Lianxin Glasses Co.,ltdTaizhou Zhejiang, ChinaManufacturer0000api.fda.gov
Taizhou Yakai Optical Glasses Co., Ltd.Taizhou Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Tangshan Zhengtong Exhibition Co., Ltd.Tangshan Hebei, ChinaManufacturer0000api.fda.gov
Techno-Aide, Inc.Whites Creek, TN, United StatesManufacturer0000api.fda.gov
Texray ABGoteborg Vastra Gotaland, SwedenManufacturer0000api.fda.gov
TF New Material Sci And Tec Co.,ltdHuainan Anhui, ChinaManufacturer0000api.fda.gov
Tianchang Jiarui Packaging Material Co., Ltd.Tianchang Anhui, ChinaManufacturer0000api.fda.gov
Tianjin Tairuibosi Medical Appliance Co., Ltd.Tianjin, ChinaExporter to the US, Manufacturer0000api.fda.gov
Tonshung Technology Co.,ltd.Tainan City, TaiwanManufacturer0000api.fda.gov
Tornado PlasticsSt-Laurent Quebec, CanadaManufacturer0000api.fda.gov
Trivitron Imaging Solutions IncScottsboro, AL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
TZ Medical, Inc.Tualatin, OR, United StatesManufacturer, Specification developer0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Ultralight Optics Inc.Westminster, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Ultraray Group Inc.Oakville Ontario, CanadaManufacturer0000api.fda.gov
Unilene, SacLima Lima(Region), PeruManufacturer0000api.fda.gov
Uniray Medical LLPNavi Mumbai Maharashtra, IndiaManufacturer0000api.fda.gov
Weihai Xingtai Packaging Products Co., Ltd.WeiHai Shandong, ChinaManufacturer0000api.fda.gov
Weilan Optical (thailand) Company LimitedMueang Samut Prakan, ThailandContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Wenzhou JT Sojos Import And Export Co.ltdWenzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Wenzhou Smart Vision Import & Export Co., LtdWENZHOU Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Wenzhou Sunrise Industrial And Trading Co., LtdWENZHOU Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Wenzhou Weilan Optical Co., Ltd.Wenzhou Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Wenzhou Zhenghai Glasses Co., LtdWENZHOU Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Wenzhou Zuoyou Medical Technoloyg Co.,ltd.Wenzhou Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Wolf X-Ray CorpBattleboro, NC, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Worldwide Innovations & Technologies, Inc.Lenexa, KS, United StatesManufacturer0000api.fda.gov
Wenzhou Tide-Optical Co., Ltd.Wenzhou Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
WestRock Converting, LLCRidgeway, VA, United StatesContract manufacturer0000api.fda.gov
Xiamen DW Optical Co.,ltdXIAMEN Fujian, ChinaManufacturer0000api.fda.gov
Xiamen Ortocare Sports Health Co.,ltd.Xiamen Free Trade Zone Fujian, ChinaManufacturer0000api.fda.gov
Xeridiem Medical DevicesTucson, AZ, United StatesContract manufacturer0000api.fda.gov
Yingtan Lante Optical Co., Ltd.Yingtan Jiangxi, ChinaManufacturer0000api.fda.gov
Yiwu Ruoxuan Garment Co.,ltdJinhua Zhejiang, ChinaManufacturer0000api.fda.gov
Zhan Jiang Kang Nian Rubber Product Co,.ltd.Zhanjiang City Guangdong, ChinaManufacturer0000api.fda.gov
Zhejiang Lidesen Medical Instrument Co., LtdHangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zhejiang Yamei Medical Equipment Technology Co., Ltd.Yang Jiao Lang Zin'an Town Zhejiang, ChinaManufacturer0000api.fda.gov
Zhongshan Chukuang Textile Co., Ltd.Zhongshan City, Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Zibo Qichuang Medical Products Co.,ltd.Zibo Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
ZOGEAR Medical Co., Ltd.Yizheng Jiangsu, ChinaManufacturer0000api.fda.gov
priMED Jiujiang Medical Products Manufacturing Co., LtdJiujiang Jiangxi, ChinaContract manufacturer0000api.fda.gov

Updated June 24, 2011. 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.