Face Masks and Surgical Masks for COVID-19
- Connexions
- 2020-11-03
- 1930
In general, masks are used by the general public and health care personnel to prevent the spread of infection or illness.
This page is for people and organizations who are new to working with the FDA. To help expand the availability of face masks and surgical masks, the FDA is providing regulatory flexibility, as described in our policy for face masks and surgical masks that is in effect during the COVID-19 pandemic.
Q: Which masks are medical devices regulated by the FDA?
A. Face masks marketed to the general public for general non-medical purposes, such as use in construction and other industrial applications, are not medical devices. Face masks, when they are intended for a medical purpose such as source control (including uses related to COVID-19) and surgical masks are medical devices.
Q: Is there a difference between a mask and a respirator?
A: Masks and respirators both cover a wearer’s nose and mouth, but they differ in several aspects.
Masks are loose fitting and may not provide full protection from breathing in airborne pathogens, such as viruses.
Face masks (non-surgical masks) may not provide protection from fluids or may not filter particles, needed to protect against pathogens, such as viruses. They are not for surgical use and are not considered personal protective equipment.
Surgical masks are fluid-resistant, disposable, and loose-fitting devices that create a physical barrier between the mouth and nose of the wearer and the immediate environment. They are for use in surgical settings and do not provide full protection from inhalation of airborne pathogens, such as viruses.
Respirators are personal protective equipment that tightly fit the face and filter airborne particles to protect health care workers. They provide a higher level of protection against viruses and bacteria when properly fit-tested. This document does not address respirators.
This CDC infographic explains the differences between surgical masks and N95 respirators.
Q: I am interested in manufacturing face masks for COVID-19. What do I need to do?
A: It will depend on the type of mask you want to manufacture.
Masks for non-medical purposes are not medical devices and are not regulated by the FDA.
The FDA has issued an EUA for face masks that meet certain criteria, including cloth face coverings recommended by the Centers for Disease Control (CDC). During the COVID-19 public health emergency, a face mask for a medical purpose that is intendedfor use as source control, is not labeled as a surgical mask, and is not intended to provide liquid barrier protection, may be authorized under the "umbrella" EUA for face masks without submitting documentation to the FDA if the face mask meets the eligibility requirements. A face mask authorized under this EUA must comply with the Conditions of Authorization (Section IV) of the EUA. Please note that this EUA does not authorize face masks for use as personal protective equipment.
-
2022-04-26Are air purifiers environmentally friendly ?
-
2022-04-26The importance of wearing a mask correctly
-
2022-04-27Connexions Air H13 True HEPA Filters
-
2022-04-29What is the use of anion function of air purifier?
-
2022-05-08Standardize the wearing of masks, children should not be missed!
-
2022-05-16Hazy days, air purifiers are useful?
-
2022-05-16Attention everyone! Don't buy fake FFP2 masks! How do we identify?
-
2022-05-17Pay attention to secondary pollution when using air purifiers
-
2022-05-17TOP5 pollutants that the purifier can purify
-
2020-06-02Why do Face Masks Matter With This Coronavirus
-
2020-06-02How to Wear Mask
-
2020-06-02Three Principles of Choice of Masks
-
2020-06-022020 Situation of Mask Market
-
2020-06-17What other preventative measures can you take to protect yourself from airborne substances?
-
2020-06-08The Advantage of Disposable Face Masks
-
2020-06-093 Ply Disposable Face Mask & Soft & Comfortable Ear Loop
-
2020-06-17What are the regulations for surgical face masks?
-
2020-06-09Do I need to wear a face mask if I am quarantined?
CONTACT US
Connexions Technology (Dongguan) Ltd.
We are always providing our customers with reliable products and considerate services.
If you would like to keep touch with us directly, please go to contact us