Copioumed AAMI 3 Surgical Gown

The Copioumed AAMI 3 Surgical Gown is a single-use, disposable, sterile protective gown intended to be worn by operating room personnel during surgical procedures. It protects both the surgical patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate materials, and is classified as AAMI Level 3 barrier protection.

The device uses SMS (spunbond-meltblown-spunbond) polypropylene nonwoven laminated with polyethylene materials. It features knit cuffs with Velcro closures (adjustable neck design), is available in sizes M, L, XL, XXL in both standard and high-performance models, and is sterilized using ethylene oxide. Key performance properties include basis weight of 40G±4G oz/yd², grab tensile strength MD≥55N and CD≥40N, tear strength MD≥10N and CD≥10N, and hydrostatic head ≥50cm.

AATCC 42 (water resistance), AATCC 127 (hydrostatic pressure), ANSI/AAMI PB70:2012 (liquid barrier performance), ASTM D3776 (basis weight), ASTM D5034 (grab tensile), ASTM D5587-15 (tear strength), ISO 10993-5/23/10 (biocompatibility), ISO 9073-10 (lint generation), 16 CFR 1610 (flammability), and EN ISO 11737-1 (sterility assurance).

The Copioumed gown is substantially equivalent to the Cardinal Health Non-Reinforced Surgical Gown (K170762) because both are Class II surgical apparel with identical product codes (FYA), similar indications for use, identical materials (SMS nonwoven polyolefin), same single-use disposable nature, identical sterilization method (ethylene oxide), and equivalent AAMI Level 3 barrier performance meeting the same testing standards and acceptance criteria.