Drape, Pure Latex Sheet, With Self-Retaining Finger Cot
Which Manufacturers in China Make This?
2 manufacturers in China hold an FDA registration for this device type, based in Guangdong and Jiangsu. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.
- Dongguan Shin YI Healthcare Products Factory Guangdong, contract manufacturer
- Jiangsu Medplus NON-Woven Manufacturer Co., Ltd. Jiangsu
How Is EYX Classified?
Drape, Pure Latex Sheet, With Self-Retaining Finger Cot is FDA product code EYX, Class 2, 21 CFR 878.4370.
What Does It Take to Sell It in the United States?
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.
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