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Regulations

  • 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™ brand transparent surgical mask also meets the CE Marking requirements as a Class I medical device under the EU Medical Device Regulation (2017/745).

  • The ClearMask™ transparent face mask meets the applicable ASTM level 3 standards for fluid resistance (ASTM F1862: 160 mmHg) and flammability (16 CFR Part 1610: Flame Spread = Class 1). Because there is no airflow through the plastic barrier, bacterial filtration efficiency, particle filtration efficiency, and differential pressure tests are not applicable.

  • Yes. Health Canada has authorized the non-medical, consumer version of the ClearMask™ brand for sale and importation as a Class 1 medical device under IO315227.

  • Yes. The ClearMask™ transparent surgical masks meet the CE Marking requirements as a Class I medical device under the European Union Medical Device Regulation (2017/745). 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). 

    In addition, UK Government Agencies have approved the non-medical, consumer version of the ClearMask™ brand for use within the UK in certain settings during the ongoing COVID pandemic. Please refer to guidance on use here.

  • 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.

  • The ClearMask™ brand produces transparent face masks, which offer distinctly different protection than transparent face shields. Face shields are not substitutes for face masks.

    “The CDC does not recommend using face shields or goggles as a substitute for masks. Goggles or other eye protection may be used in addition to a mask. Face shields and goggles are primarily used to protect the eyes of the person wearing it. Goggles do not cover the nose and mouth. Face shields are not as effective at protecting you or the people around you from respiratory droplets.” For more information about the differences, please view the CDC guidelines, specifically the “Other Types of Face Protection” section.

    The ClearMask™ brand does not make face shields of any type, only transparent face masks that cover the wearer’s mouth and nose when worn properly.

    For all available products by ClearMask™, please visit our online store.

  • The ClearMask™ brand is proudly manufactured in the United States and abroad.