510(k) K202493

Medical Face Mask by Gemtier Medical (Shanghai), Inc. — Product Code FXX

K202493 is an FDA 510(k) premarket notification submitted by Gemtier Medical (Shanghai), Inc. for the device "Medical Face Mask". The FDA issued a decision of Substantially Equivalent on Feb 4, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Gemtier Medical (Shanghai), Inc. has at least 4 other 510(k) clearances on record.