The ClearMask™ Transparent Surgical Mask Plus uses a filter material on the top and bottom portions of the mask, allowing for a tight and secure fit to the face, offering the ClearMask™ brand's best fit yet. Due to FDA regulations, data on bacterial or particulate filtration cannot be released until full FDA clearance is received. FDA 510(k) filing is in progress for the ClearMask™ Transparent Surgical Mask Plus, which is currently available for use under the FDA’s COVID-19 mask enforcement policy.
The ClearMask™ Transparent Surgical Mask Plus is not the same as an N95 respirator. Only NIOSH-approved N95 respirators are designed to fully filter with a complete seal when fit-tested and properly worn. For more information, please visit here.
For more information on filtration, please refer to the U.S. Food and Drug Administration’s website regarding masks and respirators, and the Centers for Disease Control and Prevention’s comparison on surgical masks and respirators.
The ClearMask™ Transparent Surgical Mask brand has received FDA clearance as a Class II medical device and meets the CE Marking requirements as a Class I medical device under the EU Medical Device Regulation (2017/745), which offers a high level of protection for medical use in environments such as operating rooms. The mask meets applicable ASTM Level 3 requirements in the United States for fluid resistance and flammability, and applicable EN 14683 requirements for fluid resistance, microbial cleanliness, and biocompatibility. 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 (ASTM F1671) and visibility (EN 166).
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