Gauze/Sponge, Internal
Who Makes This Device Type in China?
5 of the 8 manufacturers in China registered for this device type are contract manufacturers, able to build to a buyer’s own specification. They are concentrated in Jiangsu, Anhui and Guangdong, and 2 other provinces.
- Allmed Medical Products Co., Ltd. Hubei, contract manufacturer
- Anqing Aijing Textile Co., Ltd. Anhui, contract manufacturer
- Allmed Industrial Limited Guangdong
- Changzhou Atomic HI-Tech Radiation Co., Ltd. Jiangsu, contract manufacturer
- Derma Sciences Nantong Incorporation Jiangsu, contract manufacturer
- Jianerkang Medical Co., Ltd. Jiangsu, contract manufacturer
- Suzhou Avon Textile Co., Ltd. Jiangsu, contract manufacturer
- Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai
How Is EFQ Classified?
Gauze/Sponge, Internal is FDA product code EFQ, 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 Do the Recalls Say?
The FDA has recorded 13 recalls under this product code since 2015. None was by a company in China. The root causes the FDA records most often are Packaging (5), Material/Component Contamination (2) and Packaging process control (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.