510(k) K201974

Single-use medical face mask by Guangdong Horigen Mother & Baby Products Co., Ltd. — Product Code FXX

K201974 is an FDA 510(k) premarket notification submitted by Guangdong Horigen Mother & Baby Products Co., Ltd. for the device "Single-use medical face mask". The FDA issued a decision of Substantially Equivalent on March 7, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Guangdong Horigen Mother & Baby Products Co., Ltd. has at least 6 other 510(k) clearances on record.