Radiographic Protective Glove
Radiology · 21 CFR 892.6500
A protective radiographic glove is a "personnel protective shield." The gloves are intended to protect the operator, patient, or other person from unnecessary exposure to radiation during radiological procedures by providing an attenuating barrier to radiation. Note: These devices are not patient examination gloves or surgeon's gloves. -
Recent MDR events
6 adverse event reports on file
- PHARMA-GLOVEAug 12, 2021MalfunctionMW5103224
- FREEGUARD RADIATION ATTENUATING GLOVESDec 13, 2019MalfunctionEmerson & Co., S. R. L.MW5091677
- ESPNov 16, 2018MalfunctionBoston Scientific Corporation2134265-2018-62841
- ESPNov 16, 2018MalfunctionBoston Scientific Corporation2134265-2018-62846
- ESPNov 15, 2018MalfunctionBoston Scientific Corporation2134265-2018-62840
- PROGUARDJan 21, 2004InjuryProtech Leaded Eyewear, Inc.MW1030926
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
62 firms currently registered for this product code
Dongyang City Yonoel Outdoor Products Co.,ltd
Dongyang Zhejiang, CN
H&k International Trade Limited (china)
jinhua Zhejiang, CN
Yangzhou Feiyali Sporting Goods Co.ltd
Yangzhou Jiangsu, CN
Synergy Health Ast, Srl
Alajuela, CR
Hynaut Health Technology Co., Ltd.
Qingdao Shandong, CN
Debo Medical Technology (shijiazhuang) Co., Ltd.
Shijiazhuang Hebei, CN
Pujiang Jianyu Sanitary Products Company Ltd.
Jinhua Zhejiang, CN
Yiwu Kebon Healthcare Co., Ltd.
Yiwu Zhejiang, CN
Synergy Sterilisation (m) Sdn Bhd
Kuala Ketil Kedah, MY
Wrp Asia Pacific Sdn. Bhd.
SALAK TINGGI, SEPANG Selangor, MY
Hengshui Gangsheng Medical Instruments Co., Ltd
Hengshui Hebei, CN
Guangdong Golden Leaves Technology Development Co., Ltd.
Dongguan Guangdong, CN
Protech Leaded Eyewear, Inc.
West Palm Beach, FL, US
Emerson & Co. S.r.l.
GENOA Genova, IT
Goldendent
Roseville, MI, US
Ningbo Chibanda Imp &exp Co, Ltd
Ningbo Zhejiang, CN
Steris Spa
CALCINATE Bergamo, IT
Wolf X-ray Corp
Battleboro, NC, US
Boston Scientific Corporation
Coventry, RI, US
Wenzhou Zhusi Medical Supplies Co., Ltd
Wenzhou City Zhejiang, CN
Mb Regentox Vietnam Trading Service Company Limited
Ho Chi Minh City, VN
Suzhou Colour-way New Material Co., Ltd.
Suzhou Jiangsu, CN
Actlife Technology Co., Ltd - Thanh Hoa Branch
Trung Chinh Commune Thanh Hoa, VN
Aadco Medical, Inc.
RANDOLPH, VT, US
Dongguan City Ruimi Gift Products Co Ltd
Dongguan Guangdong, CN
510(k) clearances
5 clearances for this product code
- Burkhart Roentgen Intl., Inc.May 29, 1992
K920538 · PROTECTIVE RADIOGRAFIC GLOVE
- Hpi, Inc.Mar 7, 1991
K904878 · SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER.
- Hpi, Inc.Dec 3, 1990
K905086 · HPI TRI-RADS VINYL RADIATION PROTECTION GLOVES
- Infab Corp.May 1, 1990
K900972 · RADIATION PROTECTION GLOVES
- Boots-Celltech Diagnostics, Inc.Feb 6, 1985
K844683 · IMAGEN CHLAMYDIA TEST