510(k) K171162

Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield by Prestige Ameritech — Product Code FXX

K171162 is an FDA 510(k) premarket notification submitted by Prestige Ameritech for the device "Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield". The FDA issued a decision of Substantially Equivalent on August 15, 2017. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Prestige Ameritech has at least 5 other 510(k) clearances on record.