510(k) K101593

EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL by Exact Medical Manufacturing, Inc. — Product Code FYA

K101593 is an FDA 510(k) premarket notification submitted by Exact Medical Manufacturing, Inc. for the device "EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL". The FDA issued a decision of Substantially Equivalent on September 3, 2010. 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.