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Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the AE series surgical gowns met the requirements for Level 2 classification. Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the AG series surgical gowns met the requirements for Level 3 classification.

The Surgical Gown is a single use, disposable medical device provided as bulk, non-sterile items to repackagers/ relabler for further packaging and Ethylene Oxide (EO) sterilization. The subject device includes six models, which are provided in Table 1 Model List. The six models have the same product size, the only difference is whether the surgical gown has an inside reinforcement and material of the reinforcement. AG1001 and AE1001 don't have the reinforcement. AG2001 and AE2001 have an inside trapezoidal fabric-reinforcement on the chest and two sleeves of the gown. AG3001 and AE3001 have an inside rectangular poly-reinforcement on the chest and two sleeves of the gown.