AERO CHROME* Breathable Performance Surgical Gowns

About This 510(k) Submission

K200522 is an FDA 510(k) clearance for the AERO CHROME* Breathable Performance Surgical Gowns, 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 March 16, 2020, 14 days after receiving the submission on March 2, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.