Sidra Inc

The Sidra Medical surgical face mask is a three-layer, flat-pleated surgical face mask with ear loops and a nose piece. The device is composed of three layers of nonwoven polypropylene, with the outer layer (Layer 1) and inner layer (Layer 3) being spunbond nonwoven polypropylene, and the middle layer (Layer 2) being meltblown nonwoven polypropylene. The device utilizes two elastic ear loops, affi

xed to the facemask by heat seal, to hold the device in place over the users’ mouth and nose. The ear loops are not made with natural rubber latex. The device also utilizes a malleable nose piece, made of # # # and inserted within the layers of the face mask material, to allow the user to fit the device around the bridge of the nose. The device is sold non-sterile and intended to be a single use, disposable device. It is intended for use by healthcare personnel to protect both patients and healthcare personnel against the transfer of microorganisms, bodily fluids and particulate material. It is to be worn over the nose and mouth.