Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)

The Surgical Gown (Level 3) is a sterile, single-use disposable surgical apparel worn by healthcare professionals during surgical procedures. It provides barrier protection against the transfer of microorganisms, body fluids, and particulate matter in critical surgical zones for both patients and healthcare personnel. The gown is available in sizes S through XXXL in both standard (nonwoven) and reinforced (woven laminate) versions, and meets ANSI/AAMI PB70:2022 Level 3 liquid barrier performance requirements.

The subject device matches the predicate in product code (FYA), regulation (878.4040), classification (Surgical Apparel), performance specifications (Level 3 PB70 barrier protection), sterilization method (ethylene oxide), and design features (hook-and-loop collar closure, belt ties, knit cuffs, transfer tab, raglan or set-in sleeves). Differences include: size range (S–XXXL vs. S–XXXXL), material composition (nonwoven SMS polypropylene vs. nonwoven SMS polypropylene for standard; woven fabric laminate for reinforced), and slightly different wording of the intended use statement.

ANSI/AAMI PB70:2022 (liquid barrier performance and classification of protective apparel); AATCC 42 (impact penetration); AATCC 127 (hydrostatic pressure); ISO 10993-5 and ISO 10993-10 (biocompatibility testing for cytotoxicity, irritation, and sensitization). Testing also included microbial penetration, linting, tensile strength, burst strength, flammability, tear strength, and seam strength.