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Earloop Mask and Tie-On Mask is intended for use by healthcare workers to procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and airborne particles. This device is single-use and provided non-sterile.

Earloop Mask and Tie-On Mask is a single use non-sterile three layer mask with outer layer (Layer #1) and inner layer (Layer #3) made of spunbound polypropylene and a middle layer (Layer #2) made with meltblown polypropylene filter. Layer #1 has either no pigment (White) or a pigment (Either Blue or Green). There are 2 options for the mask to be secured on the user, either earloops or 2 sets of ties. Earloops are made of urethane elastic fiber and the ties are made of spunbound polypropylene. The nosepiece is a pliable aluminum strip covered by a polypropylene spunbound material and is encased between Layers # 1 and 2 and is affixed in place by ultrasonic heat seal. The three layers of material are pleated 3 times and Layer #3 is folded over the two other layers in front of the Layer #1. An edge material with 30 gsm spunbound polypropylene material is wrapped around the 3 layers at the 2 lateral edges. All 4 edges are ultrasonically heat sealed and ties or earloops are attached inside the edge material and ultrasonically heat sealed. All of the materials in the Standard Earloop Mask and the Standard Tie-On Mask are latex free. All materials are being used in currently marketed devices.