Screen, Leaded, Operator Radiation Protector

Which Manufacturers in China Make This?

2 manufacturers in China hold an FDA registration for this device type, based in Henan and Jiangsu. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.

Jiangsu Jumao X-Care Medical Equipment Co., Ltd. Jiangsu, contract manufacturer
Zhengzhou Henghao Optical Technology Co., Ltd. Henan

What Is FDA Product Code EAK?

Screen, Leaded, Operator Radiation Protector is FDA product code EAK, Class 1, 21 CFR 892.6500.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

Screen, Leaded, Operator Radiation Protector

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