510(k) K203591

Single-use Medical Face Mask by Conod Medical Co., Limited — Product Code FXX

K203591 is an FDA 510(k) premarket notification submitted by Conod Medical Co., Limited for the device "Single-use Medical Face Mask". The FDA issued a decision of Substantially Equivalent on Jul 2, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Conod Medical Co., Limited has 1 other 510(k) clearance on record.