510(k) K203376

ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G by Medtecs (Taiwan) Corp. — Product Code FXX

K203376 is an FDA 510(k) premarket notification submitted by Medtecs (Taiwan) Corp. for the device "ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G". The FDA issued a decision of Substantially Equivalent on March 2, 2022. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Medtecs (Taiwan) Corp. has at least 1 other 510(k) clearance on record.