If you’ve been donning a face mask every day and wondering if you have the right one—or the best one—or the most-approved one—we’re here to help. The wide range of face coverings sported by people these days is breathtaking. Pun intended. Many comply with Food and Drug Administration (FDA) guidelines. Others might not. And depending on what you do, it might not matter. Here’s a rundown of the face covering terminology and types that can help you decide which to use.
A face mask is anything that covers the user’s nose and mouth. Your covering of choice might—or might not—meet fluid barrier or filtration efficiency levels prescribed by the National Institute for Occupational Safety and Health (NIOSH) or others. But unless you are a healthcare or construction worker, it doesn’t matter. The Center for Disease Control (CDC) recommends that members of the public use simple cloth face coverings when in a public setting.
Surgical masks are face masks that meet fluid barrier protection standards and Class I or Class II flammability tests. They’re regulated under federal code 21 CFR 878.4040 as class II devices. Surgical masks fit loosely and when worn properly, they are meant to help block large-particle droplets, splashes, sprays, or splatter from reaching your mouth and nose. However, they don’t filter small particles transmitted by coughs or sneezes. Surgical masks should be used only once and discarded.
Filtering Facepiece Respirators
Filtering facepiece respirators (FFRs) are disposable, non-powered, air-purifying particulate devices. They’re designed to fit your face closely—or even seal. Commonly known as N95 respirators, they’re primary used in construction and industrial jobs that expose workers to dust and small particles. N95s are regulated by NIOSH under 42 CFR Part 84, and there are seven classes of filters for NIOSH-approved N95s.
The FDA also regulates N95s under the 21 CFR 878.4040 code as single-use, disposable healthcare devices. Surgical N95s are used in disease diagnosis, cure, mitigation, treatment, or prevention to protect against the transfer of microorganisms, body fluids, and particulates. The CDC states that N95 respirators are not for use by the general public. These are critical supplies reserved for health care workers and medical first responders. There is one thing to note here – several venues have banned “respirators“. The generally are designed to protect the wearer and therefore critical for frontline workers, but on exhale they release all or most of your breath without filtration.
You don’t see these often unless you’re at the dentist, but plastic face shields are used to protect users’ eyes and faces. Face shields are worn in addition to a face mask, not in place of one, by health care workers when aerosol spread of an infectious disease is possible and social distancing is not. For most people, they’re also a pain to wear—they distort vision and fog up, making them impractical for most day-to-day activities.
With Covid-19, manufacturers, importers, and distributors have flooded the market with face masks, face shields, and FFRs. FDA approval is not required unless they are marketed as Class II devices for medical purposes. Even then, the FDA uses a risk-based, tiered approach for regulation. The FDA “clears” Class II devices for marketing once they are shown to be “substantially equivalent” to a legally marketed predicate device. More details about manufacturing, purchasing, and importing face masks can be found at the FDA site.
Price Does Not Indicate Quality
Buying PPE supplies from huge online stores is fraught with almost as much risk as Covid-19 itself. Opportunists have flooded the market looking to make lots of quick bucks. Amazon.com has removed more than 500,000 offers of pandemic-related products and suspended more than 6,000 seller accounts for alleged price gouging. For example, just one merchant on Amazon has been using the 3M Co. name to sell masks for more than 18 times their list price. 3M has filed a lawsuit against the merchant—and is working with technology companies to remove more than 3,000 offers for counterfeit masks from online marketplaces and 4,000 deceptive posts from social media sites. Besides just price gouging, there’s also no assurance of quality or ongoing availability. Just when you need masks you might—or might not—receive a load of pure junk.
Our supplier is Secure Personal Care Products LLC. With more than 40 years of experience in providing high-quality personal care products, Secure Personal Care Products is a principal provider of PPE products for assisted living, skilled nursing, medical facilities, and municipalities. They monitor every aspect of the PPE process—from sourcing raw materials to final quality checks—and continue to reliably deliver everything from gowns, masks, face shields, and sanitizer.
Subscribe to Products and Stay Protected!
Never worry about having the right personal protective equipment on hand. We’ll make sure that you always have the supplies you need, when you need them, at an affordable cost.
Don’t know what to buy first? We’re constantly analyzing data to make your first purchase easier.
Sanitizer For Everyone
Whether you’re buying for yourself or refilling dispensers, don’t be left without quality sanitizing products!
Subscribe to PPE
Our professional grade disposable products maximize everyone’s safety. Our unique subscription service lets you set it & forget it!