Cream, Gloving, Surgeon’S
Which Manufacturers in China Make This?
One manufacturer in China holds an FDA registration for this device type, based in Tianjin.
How Is KGQ Classified?
Cream, Gloving, Surgeon’S is FDA product code KGQ, Class 1, 21 CFR 878.4470.
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.
Name
Record