510(k) K120045

EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV by Exact Medical Manufacturing, Inc. — Product Code FYA

K120045 is an FDA 510(k) premarket notification submitted by Exact Medical Manufacturing, Inc. for the device "EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV". The FDA issued a decision of Substantially Equivalent on June 12, 2012. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Exact Medical Manufacturing, Inc. has at least 8 other 510(k) clearances on record.