510(k) K010799

COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE) by Standard Textile Co., Inc. — Product Code FYA

K010799 is an FDA 510(k) premarket notification submitted by Standard Textile Co., Inc. for the device "COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE)". The FDA issued a decision of Substantially Equivalent on June 7, 2001. 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.