Dressing, Wound and Burn, Occlusive
Which Manufacturers in China Make This?
The one Chinese manufacturer registered for this device type is based in Jiangsu. 1 is a contract manufacturer.
- Derma Sciences Nantong Incorporation Jiangsu, contract manufacturer
How Is MGP Classified?
Dressing, Wound And Burn, Occlusive is FDA product code MGP, unclassified.
How Does It Reach the US Market?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.
What Has Gone Wrong With It?
The FDA has recorded 1 recall under this product code since 2011. None was by a company in China. A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.