510(k) K093169

SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE) by A Plus International, Inc. — Product Code FYA

K093169 is an FDA 510(k) premarket notification submitted by A Plus International, Inc. for the device "SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE)". The FDA issued a decision of Substantially Equivalent on November 12, 2009. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. A Plus International, Inc. has at least 10 other 510(k) clearances on record.