Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025)

These are disposable surgical gowns in four models (non-sterile and sterile versions of Level 3 and reinforced Level 4 gowns) intended to be worn by operating room personnel during surgical and invasive procedures to protect both patients and staff from transfer of microorganisms, body fluids, and particulate material. Non-sterile versions are sold in bulk for terminal sterilization via ethylene oxide before end-user distribution.

The proposed device uses SMS (spunbond-meltblown-spunbond) non-woven fabric with PET cuffs and SPP neckties, compared to the predicate's SMS and polyester materials. Weight differs (36 g/m² vs. 45 g/m² for Level 3; reinforced versions use 36+30+45 g/m² vs. predicate's 45+25 g/m²). The proposed device's breaking and tearing strengths exceed or meet predicate values. Both achieve Level 3 or Level 4 barrier classification per ANSI/AAMI PB70:2022.

ASTM F1671/F1671M-2022 (pathogen penetration), AATCC 127-2018e (hydrostatic pressure), AATCC TM42-2017 (water impact), ASTM D5034-2021 (breaking strength), ASTM D5587-2015(2024) (tearing strength), ASTM D1683/D1683M-2022 (seam strength), ISO 9073-10-2003 (linting), 16 CFR Part 1610 (flammability), ANSI/AAMI PB70:2022 (barrier classification), ASTM F2407/F2407M-2023 (acceptance criteria), ISO 10993-5/10/7 (biocompatibility).

The proposed gowns are substantially equivalent because they share identical intended use, same regulatory classification (Class II, FYA), same sterilization method (ethylene oxide, SAL 10⁻⁶), and equivalent or superior performance in all critical barrier protection tests (Level 3 and Level 4 per ANSI/AAMI PB70:2022). Material and weight differences do not affect safety or effectiveness, as demonstrated by passing biocompatibility and performance testing to applicable standards. The devices meet or exceed predicate specifications for flammability, hydrostatic pressure, water impact, breaking strength, tearing strength, linting, and pathogen penetration.