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The Unico High Performance Surgical Mask and the Unico High Performance Surgical Mask with Face Shield are 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 potential exposure to blood and body fluids. The face masks are single use, disposable device, provided non-sterile.

The Unico High Performance Surgical Mask and the Unico High Performance Surgical Mask with Face Shield are composed of four layers and are flat-pleated and offers both ear loops and tie strings types. The mask materials consist of outer layer (Polypropylene Spunbond), insertion layer (Polypropylene Spunbond) and inner layer (Polypropylene Spunbond), and middle layer filter (polypropylene melt-blown). Each mask contains ear loops or tie strings to secure the mask over the user's mouth and face with nose piece to firmly fit over the nose. The mask may also contain a face shield made from a polyethylene terephthalate film, with an anti-glare strip. The face shield is adhered to the top edge of the mask to cover the upper part of the face to prevent potential exposure to blood and body fluids. The mask(s) are single use, disposable device(s), provided non-sterile.

The Unico Global Level 3 Surgical Gown (Film-reinforced SMS) and Unico Global Level 3 Surgical Gown (PP+PE) are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the healthcare worker from the transfer of microorganisms, body fluids and particulate matter.

The subject device offers the two material models which are Unico Global Level 3 Surgical Gown (Film-reinforced SMS) and Unico Global Level 3 Surgical Gown (PP+PE). The two models use different base materials but use the same PE film layer in addition to the fabric. They have slightly different design elements in neck, body, and belt straps. The Unico Global Level 3 Surgical Gowns (Film-reinforced SMS and PP+PE) have been tested according to AATCC Test Method 127:2017, ANSI/AAMI PB70:2012, and ISO 811, and meet the AAMI Level 3 barrier level protection for a surgical gown. The Unico Global Level 3 Surgical Gowns are single use that will be provided in both sterile and non-sterile packaging configurations and offer a variety of sizes ranging from medium to XX-large.