510(k) K202845

Bodygard SFS Surgical Gown Level 3 by Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi — Product Code FYA

K202845 is an FDA 510(k) premarket notification submitted by Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi for the device "Bodygard SFS Surgical Gown Level 3". The FDA issued a decision of Substantially Equivalent on Feb 24, 2022. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi has 1 other 510(k) clearance on record.