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Level 3 Surgical Gown (Standard & Reinforced) are sterile, single-use surgical apparel intended to be worn by healthcare professionals during surgical procedures to provide barrier protection against the transfer of microorganisms, body fluids, and particulate matter in critical surgical zones for both patients and healthcare personnel.

The products meet the respective liquid barrier performance requirements for Level 3 as specified in ANSI/AAMI PB70:2022 "Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities".

Surgical Gowns are class II medical devices under the FDA product code FYA, General & Plastic Surgery Panel, and Regulation 21 CFR 878.4040. The subject surgical gowns are single use, disposable and provided sterile. They are available as Standard or Reinforced at Critical areas of the gown to increase its resistance to fluid penetration. The gowns are designed for short to medium length procedures and procedures where there is moderate risk (AAMI PB70 level 3).

The subject gowns are single-use and provided sterile (Ethylene Oxide sterilization). The subject gowns provide barrier protection against the transfer of microorganisms, body fluids, and particulate matter in critical zones of the gowns for both patients and healthcare personnel.

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