510(k) K870312

WHITE PLUME SURGICAL GAUZE FACE MASK by China National Medicines & Health Prod. I/E Corp. — Product Code FXX

K870312 is an FDA 510(k) premarket notification submitted by China National Medicines & Health Prod. I/E Corp. for the device "WHITE PLUME SURGICAL GAUZE FACE MASK". The FDA issued a decision of Substantially Equivalent on February 24, 1987. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. China National Medicines & Health Prod. I/E Corp. has at least 10 other 510(k) clearances on record.