510(k) K041653

COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS by Standard Textile Co., Inc. — Product Code FYA

K041653 is an FDA 510(k) premarket notification submitted by Standard Textile Co., Inc. for the device "COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS". The FDA issued a decision of Substantially Equivalent on July 1, 2005. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Standard Textile Co., Inc. has at least 10 other 510(k) clearances on record.