510(k) K162162

Barrier Supreme Sterilization Wrapper by Standard Textile Co., Inc. — Product Code FRG

K162162 is an FDA 510(k) premarket notification submitted by Standard Textile Co., Inc. for the device "Barrier Supreme Sterilization Wrapper". The FDA issued a decision of Substantially Equivalent on November 4, 2016. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Standard Textile Co., Inc. has at least 10 other 510(k) clearances on record.