510(k) K210445

Nordiwell Surprotect Face Mask by Changzhou Combat Protective Equipment Co., Ltd. — Product Code FXX

K210445 is an FDA 510(k) premarket notification submitted by Changzhou Combat Protective Equipment Co., Ltd. for the device "Nordiwell Surprotect Face Mask". The FDA issued a decision of Substantially Equivalent on Jun 29, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Changzhou Combat Protective Equipment Co., Ltd. has 2 other 510(k) clearances on record.