Medline Level 4 Surgical Gown with Breathable Sleeves

The Medline Level 4 Surgical Gown with Breathable Sleeves is a sterile, single-use surgical apparel worn by healthcare professionals to protect both patients and workers from microorganisms, body fluids, and particulate matter. It meets ANSI/AAMI PB70:2022 Level 4 barrier performance requirements and is available in both sterile and non-sterile (for sterilization by repackagers) versions across multiple sizes and styles.

The proposed device adds breathable film sleeves (polyester ether and polyester) and expands size availability to include 3X-Large in all three styles and X-Long in the Sirus style, compared to the predicate which did not offer these sizes. Both devices use nonwoven SMS polypropylene with anti-static and repellent properties, poly-reinforcement film on the chest, and identical hook-and-loop neck closures, waist ties, and knitted cuffs. The proposed device also offers a non-sterile bulk version for repackagers.

ISO 10993-5 (cytotoxicity), ISO 10993-23 (irritation), ISO 10993-10 (sensitization), ASTM F1671 (blood-borne pathogen resistance), AATCC 42 and 127 (water resistance), ASTM D5034 and D5587 (strength and tearing), ASTM D1683 (seam failure), 16 CFR 1610 (flammability), ASTM E96 (water vapor transmission), and ANSI/AAMI PB70:2022 (liquid barrier performance).

The proposed device performs substantially equivalent to the predicate because both share the same intended use, product code (FYA), regulatory classification, basic design features, material composition, and barrier protection level. The key differences—breathable sleeve material and expanded sizing—do not affect fundamental safety or effectiveness; the breathable sleeves enhance comfort (referenced to a different cleared device for this claim), and size expansion is a minor manufacturing variation. All non-clinical testing demonstrates the proposed device meets or exceeds the predicate's performance specifications across biocompatibility, strength, flammability, and liquid barrier standards.