Wound Dressing With Animal-Derived Material(S)
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are concentrated in Guangdong, Jiangsu and Hubei: 12 hold an FDA registration. 3 are contract manufacturers.
- Derma Sciences Nantong Incorporation Jiangsu, contract manufacturer
- Foshan United Medical Technologies Ltd. Guangdong, contract manufacturer
- Guangzhou Huada Biotechnology Co., Ltd. Guangdong, contract manufacturer
- Hubei V-Medical Products Co., Ltd. Hubei, contract manufacturer
- Huizhou Foryou Medical Devices Co., Ltd. Guangdong, contract manufacturer
- HongYu BioTech (ShenZhen) Co., Ltd. Guangdong, contract manufacturer
- Jiangsu NEW Pentastar Medical Products Co., Ltd. Jiangsu
- Jiangsu Newvalue Medical Products Co., Ltd. Jiangsu, contract manufacturer
- Roosin Medical Co., Ltd. Jiangsu, contract manufacturer
- Shenzhen JPY ION-Tech. Co., Ltd. Guangdong, contract manufacturer
- Winner Medical Co., Ltd. Guangdong
- Winner Medical Co., Ltd., Shenzhen Branch Guangdong, contract manufacturer
How Is KGN Classified?
Wound Dressing With Animal-Derived Material(S) is FDA product code KGN, unclassified.
What Does It Take to Sell It in the United States?
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. Chinese applicants hold 8 clearances under this code; the FDA took a median of 172 days from receipt to decision on them.
What Do the Recalls Say?
The FDA has recorded 23 recalls under this product code since 2015. None was by a company in China. The root causes the FDA records most often are Employee error (4), Environmental control (1) and Packaging change control (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.