510(k) K210688

AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown by O&M Halyard, Inc. — Product Code FYA

K210688 is an FDA 510(k) premarket notification submitted by O&M Halyard, Inc. for the device "AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown". The FDA issued a decision of Substantially Equivalent on July 21, 2021. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. O&M Halyard, Inc. has at least 10 other 510(k) clearances on record.