We have received U.S. Food and Drug Administration (FDA) clearance as a class II medical device transparent surgical mask.
To help meet current demand, we also have a non-medical, consumer version available at a lower price. The non-medical, consumer ClearMask™ face masks also help to improve visual communication, while still serving similar functions as traditional face masks.
Both the medical and non-medical versions are constructed using the same design and similar materials, but are manufactured in different facilities using different processes. The medical ClearMask™ has passed through the FDA 510(k) submission process and meets stringent FDA regulatory and labeling standards, including ISO13485 manufacturing standards. The non-medical, consumer version meets standard GMP practices (ISO9001 quality standards), as we strive to provide the highest quality products and service possible.
The main difference between the medical and non-medical versions of the ClearMask™ brand is the type of user and intended use:
- The non-medical version is intended for use by consumers and healthcare professionals under the FDA’s COVID-19 mask guidelines. Following these guidelines, the non-medical, consumer version is available for use in hospitals and by healthcare providers without objection from the FDA, and may be used when FDA-cleared masks are unavailable. However, per the FDA, use of these masks is not recommended in a surgical setting or where significant exposure to liquid bodily or other hazardous fluids may be expected; in a clinical setting where the infection risk level through inhalation exposure is high; or in the presence of a high intensity heat source or flammable gas.
- The FDA-cleared, medical version 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 ClearMask™ transparent surgical mask also meets the CE Marking requirements as a Class I medical device under the EU Medical Device Regulation (2017/745).