Search Results

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

The surgical masks are three-layer, flat-pleated style mask with ear loops and nose clip design for fitting the mask around the nose and mouth. The proposed device is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer (Filter layer) is made of meltblown polypropylene. The ear loops are made of nylon and spandex and the nose clip is made of galvanized iron wire. The masks not made with natural rubber latex materials, and all materials are being used in currently marketed devices. The masks will be provided in blue and the model CR02-2 will be labeled to Level 2, the CRO2 will be labeled to Level 3. The masks are single-use, disposable devices, provided non-sterile.

The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for a Surgical Mask (Model: CR02-2, CR02).

Here's the breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The device performance is reported for two models, CR02-2 (Level 2) and CR02 (Level 3), conforming to ASTM F2100 standards.

Ask a specific question about this device