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
| Country | Makers |
|---|---|
| China | 24 |
| United States | 10 |
| Vietnam | 3 |
| Malaysia | 3 |
| India | 3 |
| Costa Rica | 1 |
| Ireland | 1 |
| Italy | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Infab, LLC. | Camarillo, CA, United States | Manufacturer | 1 | May 1, 1990 | 0 | 0 | 0 | api.fda.gov |
| Aadco Medical, Inc. | Randolph, VT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Actlife Technology Co., Ltd - Thanh Hoa Branch | Trung Chinh Commune Thanh Hoa, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ansell Healthcare Products LLC | Reno, NV, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ansell N.P. Sdn. Bhd. | Melaka, Malaysia | Exporter to the US, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ashtel Studios, Inc. | Ontario, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | La Aurora Heredia, Costa Rica | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Spencer, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Limited | GALWAY Galway(County), Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cangzhou Jinkuijia Medical Devices Co., Ltd. | Cangzhou Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cangzhou Youmeiyou Rubber Products Co., Ltd. | Chang zhou Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Debo Medical Technology (shijiazhuang) Co., Ltd. | Shijiazhuang Hebei, China | Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Luda Industrial Co., Ltd | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongyang City Yonoel Outdoor Products Co.,ltd | Dongyang Zhejiang, China | Exporter to the US, Manufacturer, Repackager or relabeler | 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 | |
| Dongguan Sheng Yan Industrial Co., Ltd. | DongGuan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Emerson & Co. S.R.L. | GENOA Genova, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| F & L Medical Products LLC | Vandergrift, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Comfort Medical Products Co., Ltd. | Jiangmen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guilin HBM Health Protections, Inc. | Guilin Guangxi, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| H&K International Trade Limited (china) | jinhua Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hefei Anan Trade Development Co. Ltd. | Hefei Anhui, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hengshui Gangsheng Medical Instruments Co., Ltd | Hengshui Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huzhou Universal Glove Company Limited | Huzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hynaut Health Technology Co., LTD. | Qingdao Shandong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ineo Tech Sdn Bhd | Bandar Cassia Pulau Pinang, Malaysia | 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 | |
| Kiran Medical Systems A Div of Trivitron Healthcare Pvt. Ltd | Navi Mumbai Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MB Regentox Vietnam Trading Service Company Limited | Ho Chi Minh City, Vietnam | Foreign private label distributor, 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 | |
| Ningbo Tianbo First Aid Product Co., Ltd. | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Protech Leaded Eyewear, Inc. | West Palm Beach, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RFB Gloves | NOIDA Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Jinlai Huanhai Medical Technology Co.,ltd | Yantai Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shielding Intl., Inc. | Madras, OR, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stevimed Medical Joint Stock Company | Can Giuoc Commune Tay Ninh, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Colour-way New Material Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Uniray Medical LLP | Navi Mumbai Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wolf X-Ray Corp | Battleboro, NC, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| WRP Asia Pacific Sdn. Bhd. | SALAK TINGGI, SEPANG Selangor, Malaysia | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yancheng Trancom First Aid Supplies Industrial Co., Ltd | Yangcheng Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhou Feiyali Sporting Goods Co.ltd | Yangzhou Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yiwu Kebon Healthcare Co., Ltd. | Yiwu Zhejiang, China | Exporter to the US, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yiwu Ori-Power Medtech Co., Ltd. | YIWU Zhejiang, China | 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 |
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.