Regulations

The ClearMask™ 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:

✓	ASTM Level 3
✓	EN 14683
✓	ASTM F1671
✓	EN 166

The ClearMask™ 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™ 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™ Transparent Surgical Mask, please visit here.

For more information on CE marking for the ClearMask™ Transparent Surgical Mask, please visit here.

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.

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™ Transparent Surgical Mask Plus, 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.

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. Following the FDA’s COVID-19 mask guidelines, the non-medical, consumer version is also available for use in hospitals and by healthcare providers without objection from the FDA. 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 ClearMask™ Transparent Surgical Mask 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).

The ClearMask™ Transparent Surgical 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.

The ClearMask™ Transparent Surgical Mask Plus complies with applicable standards for fluid resistance (ASTM F1862: 160 mmHg) and flammability (16 CFR Part 1610: Flame Spread = Class 1). 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 meets the CE Marking requirements as a Class I medical device under the EU Medical Device Regulation (2017/745). It 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 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™ Transparent Surgical Mask also has received FDA clearance as a Class II medical device.

Yes. Health Canada has authorized 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).

ClearMask is registered with the United Kingdom's Medicines & Healthcare Products Regulatory Agency (MHRA) with registration number 0000018950.

No, the ClearMask™ brand produces transparent surgical masks and transparent face masks, which offer distinctly different protection than transparent face shields. The CDC does not recommend using face shields or goggles as a substitute for masks. For more information about the differences between surgical masks, face masks, and face shields, please view the CDC guidelines. The ClearMask™ brand does not make transparent face shields, only transparent surgical masks and transparent face masks that cover the wearer’s mouth and nose when worn properly.