What is FDA product code IWP?

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. -

Radiology › MiscellaneousRadiographic Protective Glove

Open Palm Mitt

Name: Open Palm Mitt
Brand: Open Palm Mitt

Open Palm Vet MItt shields back of hand. features hook & loop wrist strap and elastic loops to secure fingers 0.5mm Regular Lead

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 Open Palm Mitt
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 Open Palm Mitt
Catalogue number	Size	Status
104OPMRL		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
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

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.