Debunking common ClearMask™ misconceptions
In today’s pandemic landscape, there are many misconceptions about personal protective equipment (PPE), especially masks.
Let’s debunk some of the common myths around face masks, including our own ClearMask™ brand:
MYTH #1: Surgical masks, including ClearMask™ Transparent Surgical Masks, are supposed to filter.
Fact: Surgical masks are designed to act as a physical barrier, not as a filtering mask. Surgical masks are not N95 respirators and do not filter.
According to the U.S. Food and Drug Administration, surgical masks are “a loose-fitting, disposable device that creates a physical barrier between the mouth and nose of the wearer and potential contaminants in the immediate environment.” Surgical masks are meant to block (not filter!) large-particle droplets, splashes, liquid sprays, or splatter. All surgical masks must pass US FDA 510(k) clearance before being marketed. The ClearMask™ Transparent Surgical Mask is FDA-cleared as a class II medical device in the United States and CE-marked as a class I medical device in the European Union.
MYTH #2: Face masks and surgical masks are the same.
Fact: Face masks and surgical masks are not the same. They are defined differently by the U.S. Food and Drug Administration. Face masks are intended to be used by the general public, such as schools, retail, and at home. According to the FDA, a face mask “covers the user's nose and mouth and may or may not meet fluid barrier or filtration efficiency levels.” Face masks are not intended as medical devices.
On the other hand, surgical masks are for use in healthcare, such as operating rooms, or other medical procedures such as dental, isolation, and veterinary procedures. Surgical masks are regulated by the FDA and must go through quality and performance testing, while face masks do not.
ClearMask produces the only fully transparent, FDA-cleared and CE-marked clear surgical mask on the market: the ClearMask™ Transparent Surgical Mask, available via our online store.
MYTH #3: The ClearMask™ Transparent Surgical Mask is a face shield, and face shields can be used instead of a mask.
Fact: The ClearMask™ Transparent Surgical Mask is not a face shield. ClearMask only makes transparent surgical masks and transparent face masks that cover the wearer’s mouth and nose when worn properly.
Face shields are not designed to be a primary source of respiratory protection. When face shields are typically used in healthcare settings, they are almost always used simultaneously with a surgical face mask or respirator, since face shields are not designed to be a primary source of respiratory protection. The CDC does not recommend using face shields as a substitute for masks.