510(k) K050786

BARRIER SURGICAL GOWNS by Molnlycke Health Care — Product Code FYA

K050786 is an FDA 510(k) premarket notification submitted by Molnlycke Health Care for the device "BARRIER SURGICAL GOWNS". The FDA issued a decision of Substantially Equivalent on May 9, 2005. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Molnlycke Health Care has at least 10 other 510(k) clearances on record.