ESP™
Radiation Reduction Examination Gloves
30manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (10), Guangdong (6), Jiangsu (5). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Yangzhou Feiyali Sporting Goods Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 15 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Hynaut Health Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 68 |
| Ningbo Tianbo First AID Product Co., Ltd. | Ningbo | Zhejiang | Repacker / relabeller | 66 |
| Dongguan City Ruimi Gift Products Co Ltd | Dongguan | Guangdong | Repacker / relabeller | 62 |
| Ningbo Chibanda IMP &EXP Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 59 |
| Jcmed Tianjin Import AND Export Co., Ltd. | Tianjin | Tianjin | Manufacturer | 51 |
| Yiwu Ori-Power Medtech Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 46 |
| Hengshui Gangsheng Medical Instruments Co., Ltd. | Hengshui | Hebei | Contract manufacturer | 36 |
| Dongyang City Yonoel Outdoor Products Co., Ltd. | Dongyang | Zhejiang | Contract manufacturer | 32 |
Showing 12 of 30. All 30 manufacturers in China registered for Radiographic Protective Glove
Record
| Listed by | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | IWP |
| Device type | Radiographic Protective Glove |
| Device class | Class 1 |
| Regulation | 21 CFR 892.6500 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2019-02-21 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 3 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M001201130 | 8.5 NA Effective Length | In distribution |
| M001201140 | 9 NA Effective Length | In distribution |
| M001201110 | 7.5 NA Effective Length | In distribution |
| M001201100 | 7 NA Effective Length | In distribution |
| M001201120 | 8 NA Effective Length | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| UniRay | Uniray Medical LLP | 25 |
| Radiaxon® | Innovative Health, LLC. | 14 |
| P&P Medical Surgical LLC | P&P Medical Surgical LLC | 10 |
| Wolf X-Ray Protective Gloves | Flow X-Ray Corp. | 6 |
| Xguard | Emerson & Co. Srl | 6 |
| Protech Proguard | Emerson & Co. Srl | 6 |
| Lead Mittens | Shielding Intl., Inc. | 1 |
| Vinyl Lead Gloves | Shielding Intl., Inc. | 1 |
| Apfgxl | F & L Medical Products LLC | 1 |
| Vet Mitt | Shielding Intl., Inc. | 1 |
| APFG80 | F & L Medical Products LLC | 1 |
| 200L – Leather Lead Gloves | Shielding Intl., Inc. | 1 |
Showing 12 of 18. All products under Radiographic Protective Glove
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.