Dongguan City Xinyuan Nonwoven Co., Ltd.

Warning LetterClosed

Mr. Alex Wong Dongguan City Xinyuan Nonwoven Co., Ltd. No.8, Dajin 2nd Road, Xixi Village, Liaobu Town Dongguan Shi Guangdong Sheng , 523402 China sales01@xinyuanmask.comIssued May 27, 2021Center for Devices and Radiological Health

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations1

Issue DateMay 27, 2021

Product TypeMedical Devices

StatusClosed

Closeout LetterOct 4, 2021

Letter Details

Firm: Dongguan City Xinyuan Nonwoven Co., Ltd.
Location: Mr. Alex Wong Dongguan City Xinyuan Nonwoven Co., Ltd. No.8, Dajin 2nd Road, Xixi Village, Liaobu Town Dongguan Shi Guangdong Sheng , 523402 China sales01@xinyuanmask.com
FEI Number: N/A
Country: China
Issue Date: May 27, 2021
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Closed
Closeout Letter: October 04, 2021

Summary

Dongguan City Xinyuan Nonwoven Co., Ltd. was warned for marketing disposable medical face masks without proper FDA authorization or compliance. The company made medical claims about their products—including representations of ">90% filtration efficiency," "three layers of protection," and ability to "isolate 99% of virus"—which classified these items as medical devices under FDA regulations, yet they were being sold in the United States without required premarket approval or an Investigational Device Exemption (IDE). The FDA identified these products as adulterated devices based on website and Alibaba storefront marketing reviewed in May 2021.

Dongguan City Xinyuan Nonwoven Co., Ltd. FDA Warning Letter, May 27, 2021