Dream Medi Sterile Surgical Gown (SurgicalGownUL)

The Dream Medi Sterile Surgical Gown is a single-use, disposable surgical gown made from SMS (spunbond-meltblown-spunbond polypropylene) material, designed to be worn by operating room personnel during surgical procedures. It provides AAMI Level 3 barrier protection to protect both the surgical patient and operating room personnel from transfer of microorganisms, body fluids, and particulate matter. The gown is supplied pre-sterilized via ethylene oxide and is available in five sizes (S, M, L, XL, XXL).

The device matches its predicate (K222999) in regulatory classification, product code, material (SMS nonwoven fabric), color (blue), sterility method (EO sterilization), and AAMI Level 3 barrier performance. Key specifications are identical: impact penetration ≤1.0 g, hydrostatic resistance ≥50 cm, seam strength ≥30 N, flammability Class 1, lint generation Log10 < 4, and 3-year shelf life. Tensile and tear strength values are similar but slightly higher in the subject device.

AATCC 42 (impact penetration), AATCC 127 (hydrostatic resistance), ASTM D5034 (tensile strength), ASTM D5587 (tear resistance), ASTM D1683 (seam strength), 16 CFR Part 1610 (flammability), ISO 9073-10 (lint generation), ISO 10993-5 (cytotoxicity), ISO 10993-23 (irritation), ISO 10993-10 (sensitization), and ISO 11135:2014 (EO sterilization).

The subject device is substantially equivalent because it shares identical intended use, regulatory classification (Class II, 21 CFR 878.4040), product code (FYA), materials (SMS nonwoven), and design (raglan sleeves, hook-and-loop neck closure, tie waist). All critical performance parameters are identical or superior to the predicate: barrier performance, flammability, and biocompatibility results are equivalent. The device uses the same sterilization method and achieves the same AAMI Level 3 protection standard, with non-clinical testing demonstrating it meets or exceeds the predicate's safety and performance specifications. No clinical data was needed because the device is substantially similar in form, function, and performance characteristics to the legally marketed predicate.