The ClearMask™ brand transparent surgical mask has received FDA clearance as a Class II medical device in the United States, meets the CE Marking requirements as a Class I medical device under the EU Medical Device Regulation (2017/745), and meets applicable standards for:
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The ClearMask™ brand transparent surgical mask is designed to block the transfer of aerosols, fluids, and sprays using an anti-fogging plastic barrier. There is no airflow through the impervious plastic barrier; therefore bacterial and particulate filtration efficiency and differential pressure tests are not applicable. The ClearMask™ brand transparent surgical mask meets the applicable standards for fluid resistance, flammability, microbial cleanliness, and biocompatibility.
The ClearMask™ transparent surgical mask meets requirements 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 ClearMask™ transparent surgical mask has also passed additional tests in accordance with the transparent mask guidelines released by the United Kingdom, including tests for resistance to penetration of microorganisms and visibility. Additionally, Health Canada has authorized the ClearMask™ brand for sale and importation as a Class 1 medical device under IO315227.
For more information on FDA clearance for the ClearMask™ brand, please visit here.
For more information on CE marking for the ClearMask™ brand, please visit here.
FDA 510(k) filing is in progress for the ClearMask™ High Filtration Transparent Surgical Mask, which is currently available for use under the FDA’s COVID-19 mask enforcement policy.