AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown

About This 510(k) Submission

K210688 is an FDA 510(k) clearance for the AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown, a Gown, Surgical (Class II — Special Controls, product code FYA), submitted by O&M Halyard, Inc. (Mechanicsville, US). The FDA issued a Cleared decision on July 21, 2021, 135 days after receiving the submission on March 8, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.