Guidelines prescribed by the FDA for using surgical masks

A surgical mask is a specific type of face mask that went on to replace cloth masks after its invention. Cloth masks, which were previously used by physicians when treating patients with contagious illnesses became obsolete in the medical field after the advent of surgical masks. A surgical mask was created for the specific purpose of protecting the people involved in the healthcare sector, which is why it is also known as a ‘medical mask’. Surgical masks are widely used in hospitals during various medical procedures and are also being used by the masses as a means of protection against COVID-19.

The material used in the manufacturing of a surgical mask is polypropylene which is a kind of synthetic plastic obtained through the melt blowing process. A surgical mask is responsible for filtering out contaminated droplets and fluids as splashes but the mask is unable to filter out particulates other than fluids. A surgical mask's maximum efficiency is 90% and the minimum efficiency is 10%. The quality of a surgical mask can vary according to its manufacturers and not all surgical masks are medical masks.

Use of surgical masks in the US

America was one of the first countries to normalize the use of surgical masks in healthcare settings. It was also widely used during the pandemic. Although respirators were the recommended PPE for healthcare professionals as they provide better protection because there was a huge scarcity of respirators hospitals had begun to use surgical masks. The Food and Drug Administration, which is a federal agency of the United States’ department of health and human services is headquartered in South Spring, Maryland. The FDA was the one to allow the usage of surgical masks in America before long before the pandemic began.

According to the CDC and FDA, if worn properly surgical masks, to some extent, can help prevent coronavirus. FDA is also the one responsible for the clearance of these products. Other agencies like CDC, OSHA, and NIOSH are also responsible for testing out and approving PPE such as the surgical masks and N95 respirators. FDA has also prescribed some guidelines on the usage of surgical masks that also enables the user to the mask safely.

1- FDA’s Policy on reusing surgical masks

The FDA and CDC do not recommend reusing old surgical masks. The best way of using a surgical mask is to wear it for a one time use only and discard them after each use. However, during these unprecedented times where surgical marks are available in a rather sparse amount, CDC has come up with conversation methods which are also approved by the FDA.

2- FDA’s Criteria for approval

To ensure the safety of the healthcare professionals and other users of this product, the FDA has meticulous criteria that must be fit by a surgical mask to gain the FDA’s approval for marketing. An umbrella EUA has also been issued by the FDA that determined whether a surgical mask is fit for use in a healthcare setting or not. This criterion includes requirements like efficient filtration, satisfactory liquid barrier performance, resistance against air-flow and it must also include biocompatible. Furthermore, the materials used in making a surgical mask should be non-irritating, non-sanitizing, and non-cytotoxic.

3- Precautions prescribed by the FDA

Surgical masks include various chemical components and it not very unlikely that a user may have an allergic reaction to any of them. Since a surgical mask has direct contact with the user’s face and stays there for a prolonged time, some users can also experience irritation because of that. FDA further recommends that a user must assess the biocompatibility of the materials included in the surgical mask. If there is a predicate device available then the user can assess that device and its material before buying the actual mask.

Why the FDA guidelines are important

The FDA is responsible for the protection and promotion of public health. It is also concerned with food safety and other kinds of matters that are ultimately related to public health. Guidelines that are prescribed by the FDA are crucial for ensuring public safety and efficient use of PPE such as surgical masks and N95s. Moreover, the precautions that are prescribed by the FDA will help the user be prepared in advance for any mishaps that could occur by using a surgical mask. It will also help a user in deciding whether a surgical mask is best suited for them or not. Aside from this, the FDA’s policy and criteria for the approval of a surgical mask plays an important role in maintaining the quality and standards of a surgical mask and also ensures that the surgical masks presented to the public and healthcare workers are indeed authentic and effective.


The use of surgical masks is prevalent in not the only USA but the rest of the world too. It is primarily used in the healthcare sector but besides that, the inhabitants of some Asian countries also wear it for protection against pollution and influenza. However, the recent pandemic has amplified the importance of this mask as this mask is also being used by the frontline workers and the general public to seek protection against COVID-19. In this connection, the FDA has prescribed a set of guidelines for everyone on the proper usage and handling of a surgical mask. Aside from this, the FDA has also devised a very strict testing policy for surgical mask manufacturers that is crucial in maintaining that masks’ efficacy.

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