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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 Level 2 standard surgical gowns met the requirements for Level 2 classification, the Level 3 standard surgical gowns and Level 3 reinforced surgical gowns met the requirements for Level 3 classification.

The proposed devices are 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. The proposed devices are single use, disposable medical devices and are provided in sterile. There are three types of surgical gown: Level 2 standard surgical gown, Level 3 standard surgical gown and Level 3 reinforced surgical gown. And each type of surgical gown is available in seven product sizes, including XS, S, M, L, XL, XXL and XXXL. The barrier protection level for Level 2 standard surgical gown meets AAMI Level 2, while the barrier protection level for Level 3 standard surgical gown and Level 3 reinforced surgical gown meet AAMI Level 3.

The device is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.

The proposed devices, Standard Procedure Mask and Standard Surgical Mask, are a three-layer, singleuse, flat-pleated mask. Both the two masks have the same indications for use. The Standard Procedure Mask is an ear-loop surgical mask, and the Standard Surgical Mask is a tie-on surgical mask. The color of the proposed devices is blue. They are provided in non-sterile.