Medical Gowns With Chemotherapy Labeling Claims – Tested for Use With Chemotherapy Drugs
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are based in Taiwan and Zhejiang: 2 hold an FDA registration.
- Copioumed International, Inc. Taiwan
- Hangzhou Jincheng Medical Supplies Manufacture Co., Ltd. Zhejiang, contract manufacturer
What Is It?
Medical gowns that are worn by healthcare personnel to protect both the patient and the wearer from transfer of microorganisms, body fluids, and particulate material. In addition, these gowns have been tested for permeation and breakthrough resistance against various concentrations and types of chemotherapy drugs.
How Is QSO Classified?
Medical Gowns With Chemotherapy Labeling Claims – Tested For Use With Chemotherapy Drugs is FDA product code QSO, Class 2, 21 CFR 878.4040.
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.