Lead Mittens

Lead mittens - 15" one piece dip molded

Registry build 21.09.26
30manufacturers in China registered for this device type
1catalogue number

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.

Chinese manufacturers registered for FDA product code IWP
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

Regulatory record for Lead Mittens
Listed by Shielding Intl., Inc., United States
FDA product code IWP
Device type Radiographic Protective Glove
Device class Class 1
Regulation 21 CFR 892.6500
Establishment Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2023-08-08

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Lead Mittens
Catalogue number Size Status
101MITRL In distribution

Same Product Code

Other products under the same FDA 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
ESP™ Boston Scientific Corporation 5
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer