510(k) K242844

Medline Level 4 Surgical Gown with Breathable Sleeves by Medline Industries, LP — Product Code FYA

K242844 is an FDA 510(k) premarket notification submitted by Medline Industries, LP for the device "Medline Level 4 Surgical Gown with Breathable Sleeves". The FDA issued a decision of Substantially Equivalent on February 26, 2025. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Medline Industries, LP has at least 10 other 510(k) clearances on record.