Aero Blue Performance Surgical Gowns

About This 510(k) Submission

K192362 is an FDA 510(k) clearance for the Aero Blue 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 December 13, 2019, 105 days after receiving the submission on August 30, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.