Our surgical face masks are FDA and CE (European) certified.
What is a surgical mask?
If worn properly, a surgical mask is meant to help block large-particle droplets, splashes, sprays, or splatter that may contain germs (viruses and bacteria), keeping it from reaching your mouth and nose. Surgical masks may also help reduce exposure of your saliva and respiratory secretions to others. As they are designed to be used in an operating room, they can be used for up to 3 hours before needing to be disposed.
There are 2 governing bodies that have standards – the US standards, by the ASTM, and the European standards.
Surgical masks must meet a minimum requirement of filtering out 95% of bacteria, and 3 other requirements.
ASTM Standards (FDA/US):
The ASTM has 3 levels of certification – ASTM level 1,2 and 3. Each has certain minimum requirements. These masks are level 1. They have been meltblown and have 3 layers of protection. These will be better than your non-certified masks that haven’t been proven to stop all moisture for up to 3 hours (coughs, sneezes etc), and will stop 95% of bacteria. Surgical masks are not intended to be used more than once. If your mask is damaged or soiled, or if breathing through the mask becomes difficult, you should remove the face mask, discard it safely, and replace it with a new one. To safely discard your mask, place it in a plastic bag and put it in the trash. Wash your hands after handling the used mask.
The CE has 3 levels of certification – FFP1, FFP2 and FFP3.
Our surgical masks are certified as FFP1.
See more about Face mask protection in the resources below:
Beware of fakes/non-certified masks:
Unfortunately, there are many scammers galore with the current mask shortage. We buy factory direct, ensure that the factory has all of the required certifications and inspect all of the boxes before they leave the factory.
There are many sellers online that are selling face masks that aren’t certified. Please make sure to check before you buy.
What should a medical practitioner use?
Ideally, medical practitioners should be using respirator masks. These masks have a much smaller particulate filter. They do require experience tightening properly, but ensure that a minimum of 98% of bacteria can not penetrate the mouth. It is also advised that practitioners use eye goggles or face shields.
In terms of certification, the CDC has a NIOSH certification, and those masks are called “N95’s”. There are very few companies that are actually NIOSH certified. In CE certification, those are called FFP2’s.
Due to the scarcity of masks that are certified, the FDA has released guidelines allowing KN95’s (the chinese equivalent) to be used by practitioners.