Zhejiang Xichen Medical Technology Co., Ltd. Warning Letter Details

Summary

Zhejiang Xichen Medical Technology Co., Ltd. was cited for illegally marketing face masks—including KN95 respirators, medical face masks, and surgical masks—as medical devices intended to prevent, treat, or diagnose COVID-19 and other diseases without proper FDA authorization or premarket approval. The company made specific disease claims on its website, such as representing the KN95 mask as a "COVID-19 Respirator" with antibacterial properties to "prevent bacteria, droplets and other harmful particles" and marketing medical masks to "prevent infection" and provide protection during epidemics or pandemics. These marketing claims established the products as medical devices under the Federal Food, Drug, and Cosmetic Act but were made without the required IDE or PMA submissions to FDA.