510(k) K192362

Aero Blue Performance Surgical Gowns by O&M Halyard, Inc. — Product Code FYA

K192362 is an FDA 510(k) premarket notification submitted by O&M Halyard, Inc. for the device "Aero Blue Performance Surgical Gowns". The FDA issued a decision of Substantially Equivalent on Dec 13, 2019. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. O&M Halyard, Inc. has 25 other 510(k) clearances on record.