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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.