510(k) K162930

Aero Chrome* Select Breathable Performance Surgical Gowns by Halyard Health, Inc. — Product Code FYA

K162930 is an FDA 510(k) premarket notification submitted by Halyard Health, Inc. for the device "Aero Chrome* Select Breathable Performance Surgical Gowns". The FDA issued a decision of Substantially Equivalent on April 21, 2017. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Halyard Health, Inc. has at least 10 other 510(k) clearances on record.