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The Surgical Isolation Gown is intended to protect health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Surgical Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70).The Surgical Isolation Gown is a single use, disposable medical nonsterile.

The proposed SURGICAL Isolation Gown is constructed of polyolefin (Polypropylene) SMS nonwoven material with the color in yellow. The SURGICAL Isolation Gowns consist of a one critical zone throughout the entire gown including seams but excluding cuffs, hems, and bindings. The product has been tested for barrier performance per ANSI/AAMI PB70:2012. Testing was performed according to the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993 and ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities. All results of testing met AATCC-42/AATCC-127, and meets AAMI PB70:2012 Level 3 requirements.