The ClearMask™ brand transparent surgical mask meets the CE Marking requirements as a Class I medical device under the EU Medical Device Regulation (2017/745). It is intended for use in healthcare settings, such as operating rooms, or other medical procedures such as dental, isolation, and veterinary procedures during which a face mask is necessary to protect both the patient and healthcare personnel from transfer of body fluids, microorganisms, and particulate material. The mask meets applicable EN 14683 requirements for fluid resistance, microbial cleanliness, and biocompatibility, which offers a high level of protection for medical use in environments such as operating rooms.
The ClearMask™ transparent surgical mask also passed additional tests in accordance with the transparent mask guidelines released by the United Kingdom, including tests for resistance to penetration of microorganisms (ASTM F1671) and visibility (EN 166).
The ClearMask™ brand transparent surgical mask also has received FDA clearance as a Class II medical device.