Our adult-size ClearMask™ transparent surgical mask brand has received U.S. Food and Drug Administration (FDA) clearance as a class II medical device transparent surgical mask. It has passed through the FDA 510(k) submission process and meets stringent FDA regulatory and labeling standards, including ISO13485 manufacturing standards. 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.
We also have a non-medical, consumer version available for children. The non-medical, consumer ClearMask™ meets standard GMP practices (ISO9001 quality standards), as we strive to provide the highest quality products and service possible.
Both the adult and child-size masks offer excellent protection. 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 medical version meets requirements for use in general populations, 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).