Frequently Asked Questions
Is The ClearMask CE Certified (EU and UK) and FDA Approved (USA)?
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) and can be used in hospitals, clinics, schools, and other settings. The mask is optimized for maximum clarity and comfort, meeting 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.
In the United States, the ClearMask™ brand received FDA clearance as a Class II medical device on April 6, 2020, and meets applicable ASTM Level 3 requirements in the United States for fluid resistance and flammability. 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 – Why is wearing a ClearMask important?
The ClearMask: Over half of communication is visual. We often depend on facial expressions and visual cues when we communicate with others. As humans, we are highly attuned to facial expressions and emotions, even on a subconscious level.
As the first fully transparent, FDA-cleared surgical mask, a ClearMask helps improve communication for everyone. The ability to see others’ facial expressions and emotions can improve the patient-provider relationship and quality of care. When individuals are able to see each other’s faces and smiles, outcomes such as patient satisfaction, trust, and health can improve.
How do I wear the ClearMask?
The mask is available in two different strap styles, EZ-Adjuster, and tie-on. Check out our user manual and demo video on how to properly wear the ClearMask. Instructions in English, Spanish, and French are available.
Does the ClearMask provide as much protection as a traditional mask? Does it protect me against COVID-19?
Traditional masks are designed to block bodily fluids and particulate materials away from the wearer’s face. The ClearMask™ serves the same functions as traditional masks and provides a full, anti-fog plastic barrier, which helps prevent particles or droplets from getting through. The ClearMask™ is not airtight along the sides of the mask, where air circulation occurs, thus allowing for comfort and breathability. All traditional masks have gaps on the sides, so this design is not entirely unique to the ClearMask™. Only N95 respirators do not have gaps and are able to filter, with a full seal when fit-tested and properly worn.
What is the ASTM level rating for the ClearMask?
The ClearMask meets the applicable ASTM Level 3 standards for fluid resistance (ASTM F1862: 160 mmHg) and flammability (16 CFR Part 1610: Flame Spread = 1). Because there is no airflow through the plastic barrier, bacterial filtration efficiency, particle filtration efficiency, and differential pressure tests are not applicable to the ClearMask.
Does the ClearMask filter?
The ClearMask is not the same as an N95 respirator. Only N95 respirators are designed to filter with a full seal when fit-tested and properly worn.
Is the ClearMask reusable?
The ClearMask is for single-use only and is not intended to be reused. The mask is designed for indoor settings and recommended for use at room temperature, in ventilated, low-humidity environments, such as indoor offices or clinics.
Are there different sizes?
The masks are one size only and are designed to fit adults’ faces. The mask can be adjusted for a tighter or more personalized fit.
Do ClearMasks fog up?
The ClearMask’s plastic barrier has an anti-fog coating that minimizes fogging when the wearer is speaking or breathing. The mask is designed for indoor settings and recommended for use at room temperature, in ventilated, low-humidity environments, such as indoor offices or clinics. The masks are also single-use only and is not intended to be reused.
Is the ClearMask latex-free?
Yes, the ClearMask is latex-free.
Is the ClearMask FDA-cleared?
We have received U.S. Food and Drug Administration (FDA) clearance on the ClearMask as a class II medical device transparent surgical mask, and the FDA-cleared version will be available in a few weeks via our online store. You can sign up and be notified when the FDA-cleared masks are available by visiting the specific product’s page and clicking on the register button. We also have a non-medical version of the ClearMask available at a lower price to meet the demand. The non-medical, consumer face mask similarly helps to improve visual communication and provide protection.
Following the FDA’s COVID-19 mask 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. 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 of the ClearMask 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.
Does the ClearMask replace sign language interpreters?
No. Because the ClearMask is an auxiliary aid, it is only designed to improve communication between all parties, not to replace the users’ preferred accommodations. Healthcare providers should always ask their patients about their preferred accommodations before administering care.
Are hospitals and doctors required to provide ClearMasks?
Under both the Americans with Disabilities Act and the Affordable Care Act, entities are required to provide effective accommodations upon request, including auxiliary aids. The ClearMask is an auxiliary aid.
Where can I purchase wholesale bulk orders of the ClearMasks?
To enquire about wholesale or bulk orders of the ClearMask, please contact Nice2cu customer support at: https://nice2cu.com/contact-us.