Many ask if wearing a surgical mask can help reduce the spread of coronavirus or what is otherwise known as COVID-19. Yes, it has been proven that the use of surgical masks and face coverings can help in the reduction of the spread. Surgical masks, and the use of frequent handwashing along with social distancing can and will help to reduce the spread. 

Another question that has been asked numerous times is then why weren’t we instructed to wear surgical masks at the start of the pandemic? The best answer possible is in the beginning of COVID-19 the experts were not 100% sure of the magnitude to which the extent of individuals diagnosed with COVID-19 could spread COVID-19 before symptoms showed themselves. Both those with and without symptoms can spread the illness.   

With the newest discoveries made about the virus public health groups changed their recommendations on the wearing of surgical masks and face coverings. The U.S. Centers for Disease Control and Prevention (CDC) and The World Health Organization have now included surgical masks and facial coverings in the recommendations for the public in the slowing of the coronavirus spread. It is important to note that medical surgical masks and N95 masks are not recommended to be worn by those in the public and these should be saved for those in the medical fields where needed. 

Understanding what the different types of surgical masks are and the protection they provide can be confusing. Here, we will discuss the different types of masks and whether they are FDA cleared. 

What is a surgical mask? 

A mask that is considered a surgical mask is disposable and loose-fitting. The mask is used to form a barrier between the nose and mouth of the individual wearing it and contaminants in the surrounding environment. These masks are regulated under the 21 CFR 878.4040. Surgical masks are never to be shared with another individual and can be labeled by different names including isolation, medical procedure, and dental. They may come without or with a face shield. These are sometimes called face masks; it is important to note that not all masks are regulated as true surgical masks. 

Different types of surgical masks protect the individual from encountering different types of fluids or liquids and come in different thicknesses. The thickness and protection offered will also have an effect on how easy they are to inhale and exhale through, and the exact amount of protection offered. 

If the mask is worn properly it will help to block out splashes, large-particle droplets, and splatters that may contain bacteria or viruses from reaching the mouth or nose. These masks may also help to reduce the exposure of your respiratory secretions and saliva to others. 

A regular surgical mask is designed to keep secretions and splashes from reaching the nose or mouth; they are not designed to block or filter miniscule particles that are in the air. These exceedingly small particles can be transmitted by sneezes, medical procedures, or coughs. A loosely fitting surgical mask also does not offer protection from contaminants and germs between the surfaces of the individuals face and mask. 

Once the mask becomes soiled or damaged or gets hard to breathe through, they should be discarded. The old mask should be discarded by carefully removing and placing in a plastic bag. The plastic bag should then be placed in an appropriate trash receptacle. Once the bag is discarded the hands should be washed thoroughly and a new mask put on. 

What is an N95 Respirator? 

An N95 respirator is a protective device that is a respirator. These respirators are specially designed to provide highly effective filtering of airborne particles and fit very snuggly on the face. A tight seal is formed around the mouth and nose by the way they are designed. These masks are most used in different healthcare settings. N95 respirators are considered a subset of N95 Filtering Facepiece Respirators and are often called FFRs. The things that N95 respirators have in common with the typical surgical masks are:

  • They should never be reused or shared with another individual. 
  • They are always tested for filtration efficiency, biocompatibility, and flammability. 

The Centers for Disease Control and Prevention has never recommended the public use N95 respirators for protection from bacteria and viruses including the COVID-10 (coronavirus). These respirators are medical supplies that are considered critical and should be reserved for medical first responders and other healthcare providers.

Although the N95 respirators were in high demand and hard to come by many hospitals in the United States, companies have stepped up in the manufacturing of these respirators. 

One such company is Honeywell. On March 30, 2020, Honeywell announced that it was improving on manufacturing implementations in their Phoenix location to meet the government's response for need. Honeywell had already set manufacturing in place in their Rhode Island location. Honeywell would now be able to manufacture about 20 million N95 masks monthly to help reduce the spread of COVID-19. New equipment that is state of the art was due to arrive at the Phoenix plant in March. 

Honeywell continues to recruit, train, and hire workers for both their Rhode Island and Phoenix locations. Not only is this helping to keep our healthcare workers and first responders safe it is helping the American economy. 

Where and How are Surgical Masks Made? 

With the major shortage of surgical masks during this pandemic people and businesses are concerned about where to order from. When the recommendation was first put out by the CDC there was hoarding that was taking place. Now, questions are arising, and answers are hard to find. Is it safe to order surgical masks from other countries? Can the virus live on the masks that are coming in from other countries? 

A Surgical mask can be made all over the world. In fact, half of all surgical masks were manufactured in China where the coronavirus was born. Since then, the production of masks has expanded greatly in China. The problem is, this country has kept the masks for themselves and reduced exportation. 

Now, other countries are in demand of masks and governments around the globe are not allowing exports of PPE and many are concerned that this could make the spread of the pandemic worse.

With more people returning to work there are more masks needed now than ever before. If masks are not worn the pandemic could get worse and this is trying to be avoided. 

Surgical masks are now being made all over the United States and manufacturing has been amped up tremendously. 

History of Surgical Masks

The first disposable surgical came out in the 1930’s. The act of covering the nose and mouth with a type of mask has been part of medicine to protect against disease since the early modern Europe times. It was a common practice to have spices or perfumes under the masks as an added protection. These practices however ended in the 18th century. 

British surgeon Joseph Lister came up with the idea that wound disease was caused by the microscopic germs that Louis Pasteur had just described to others. Mr. Lister then suggested eliminating germs by using antiseptics. Though, in the 1880’s, younger surgeons devised a plan that targeted the idea to stop germs from getting in wounds to begin with. This is when the idea of even the surgeons and medical staff exhalations could be suspected of causing problems. 

Masks were used to cover the face in the Manchurian plague 1911 and the pandemic known as influenza in 1919. During this time, the earliest forms of the surgical mask were used outside of the medical industry. Some US cities enforced the wearing of masks with residents and police forces.  

Meantime, surgical masks were being improved upon in the medical world. Although doctors agreed that masks worked, they were trying to agree on the most efficient types of masks. Even at this early stage there were patents in place on various types. 

The earlier masks were normally manufactured by placing many layers of gauze made of cotton. Some masks included one layer of impervious material that was held in place by a small metal frame. The main goal of these masks was to stop respiratory droplets from being between the wearers and patients. Most of these early masks were washable and the parts containing metal could be sterilized. 

FDA Cloth Face Covering Recommendations

The FDA has posted the following recommendations. Cloth face coverings whether brought from home or given by the employer are not considered disposable facemasks or respirators and do not protect individuals from exposures. 

Cloth face coverings only contain the wearers respiratory excretions and droplets from being spread. These cloth coverings should never be used in place of an FDA cleared surgical mask or respirator. 

The CDC states that these types of cloth face coverings help to diminish the spread of the virus that is responsible for the COVID-19 pandemic.

Workers should wear these cloth face masks if the employer has determined that disposable face masks or respirators are not on the workplace hazard assessment.

If the cloth face mask becomes wet, soiled, or hard to breath through during the work shift it should be replaced by a disposable surgical mask or clean cloth face covering. 

Many have begun to make their own facial coverings and it’s suggested that cotton materials be used. 

Proper way to wear a cloth mask includes the following: 

The mask should always fully cover the mouth and nose. Should be fitted below the chin.

The covering should fit as snuggly against the sides of the face as possible without being too constricting.

Be held securely with ear loops or ties.

Covering should be manufactured with multiple layers of fabric and allow for unrestricted breathing.

Be able to be machine washed and dried.

FDA Cleared Surgical Masks During COVID-19

It has always been the task of the FDA to have a critical role in the protection of those in the United States from harmful threats that include diseases that are highly infectious which includes the Coronavirus Disease pandemic. The FDA has been fully committed to providing guidance and response times when it comes to this pandemic. 

During the COVID-19 pandemic the FDA has issued the following for compliance in surgical masks:

During this pandemic, the FDA has taken many steps to help ensure that medical devices that are critical are available for use. The FDA has recently issued specific requirements for personal protective equipment and ventilators with listing requirements and registration enforcement. 

The FDA has issued Emergency Use Authorizations for devices considered critical PPE devices including surgical masks and N95 respirators. For those who are interested in manufacturing FDA surgical masks that are FDA cleared it is important to follow the registration and listing guidelines that can be found here: https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/registration-and-listing-medical-devices-during-covid-19-pandemic#emergency.

Is This Surgical Mask Safe and Cleared by the FDA?

It is important to note that there may be surgical mask manufacturers that deem that their product is FDA cleared. Because there is a quote saying this does not mean it is factual. To look up a surgical mask and type to be sure it is FDA cleared here is the FDA website page to verify: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

Locations that produce and sell FDA cleared surgical masks include: 

  • N95 Mask Company 
  • Honest PPE Supply
  • B8 Sales, Inc.
  • Baer Global Group
  • Blue Golf, LLC
  • 3M
  • Honeywell International
  • HSG Safety Supplies
  • Majestic Glove
  • Master and Frank Enterprise Co.

The CDC does have a list of manufacturers and suppliers on the website to help those who are trying to locate surgical masks and respirators. 

As with any other type of illness or pandemic it is imperative that we keep medical staff, residents, and medical workers as safe as possible and reduce the risk of spread. Through due diligence and the use of surgical masks and respirators we will conquer this.

Our medical workers and first responders are overworked and manufacturers around the United States are doing their best to help protect them by producing FDA cleared surgical masks.

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