510(k) K230610

Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series) by Dongguan Shin YI Healthcare Products Factory — Product Code FYA

K230610 is an FDA 510(k) premarket notification submitted by Dongguan Shin YI Healthcare Products Factory for the device "Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series)". The FDA issued a decision of Substantially Equivalent on August 23, 2023. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Dongguan Shin YI Healthcare Products Factory has at least 1 other 510(k) clearance on record.