510(k) K202843

Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) by B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. — Product Code FXX

K202843 is an FDA 510(k) premarket notification submitted by B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. for the device "Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)". The FDA issued a decision of Substantially Equivalent on Jan 12, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. has 4 other 510(k) clearances on record.