510(k) K214035

LAITEST Medical Face Mask by R&R Medical Corporation, Ltd. — Product Code FXX

K214035 is an FDA 510(k) premarket notification submitted by R&R Medical Corporation, Ltd. for the device "LAITEST Medical Face Mask". The FDA issued a decision of Substantially Equivalent on Sep 13, 2022. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. R&R Medical Corporation, Ltd. has 1 other 510(k) clearance on record.