510(k) K203418

Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage)) by Ningbo Ouhan Medical Device Co., Ltd. — Product Code FXX

K203418 is an FDA 510(k) premarket notification submitted by Ningbo Ouhan Medical Device Co., Ltd. for the device "Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))". The FDA issued a decision of Substantially Equivalent on Sep 17, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.