N95
Respirators, Surgical Masks, and Face Masks

N95 Respirators, Surgical Masks, and Face Masks

N95 respirators and surgical masks are examples of personal protective equipment
that are used to protect the wearer from airborne particles and from liquid
contaminating the face. The Centers for Disease Control and Prevention (CDC)
National Institute for Occupational Safety and Health (NIOSH) and the
Occupational Safety and Health Administration (OSHA) also regulate N95 respirators.

It is important to recognize that the optimal way to prevent airborne transmission is
to use a combination of interventions from across the hierarchy of controls,
not just PPE alone.

CDC
Recommendations for the General Public

CDC
recommends that people wear masks in public
settings, at events and gatherings, and anywhere they will be around
other people. Effective February 2, 2021, CDC issued an order requiring masks on
planes, buses, trains, and other forms of public transportation traveling into,
within, or out of the United States and in U.S. transportation hubs such as
airports and stations.

Surgical Masks

A surgical mask is a loose-fitting, disposable device that creates a physical
barrier between the mouth and nose of the wearer and potential contaminants in
the immediate environment. Surgical masks are regulated under 21 CFR 878.4040.
Surgical masks are not to be shared and may be labeled as surgical, isolation,
dental, or medical procedure masks. They may come with or without a face shield.
These are often referred to as face masks, although not all face masks are
regulated as surgical masks.

Surgical masks are made in different thicknesses and with different ability to protect
you from contact with liquids. These properties may also affect how easily you
can breathe through the face mask and how well the surgical mask protects you.

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.

While a surgical mask may be effective in blocking splashes and large-particle
droplets, a face mask, by design, does not filter or block very small particles
in the air that may be transmitted by coughs, sneezes, or certain medical
procedures. Surgical masks also do not provide complete protection from germs
and other contaminants because of the loose fit between the surface of the mask
and your face.

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.

N95 Respirators

An N95 respirator is a respiratory protective device designed to
achieve a very close facial fit and very efficient filtration of airborne
particles. Note that the edges of the respirator are designed to form a seal
around the nose and mouth. Surgical N95 Respirators are commonly used in
healthcare settings and are a subset of N95 Filtering Facepiece Respirators
(FFRs), often referred to as N95s.

Comparing Surgical Masks and Surgical N95
Respirators

The FDA regulates surgical masks and surgical N95 respirators differently based on
their intended use.

A surgical mask is a loose-fitting, disposable device that creates a
physical barrier between the mouth and nose of the wearer and potential
contaminants in the immediate environment. These are often referred to as face
masks, although not all face masks are regulated as surgical masks. Note that
the edges of the mask are not designed to form a seal around the nose and
mouth.

An N95 respirator is a respiratory protective device designed to
achieve a very close facial fit and very efficient filtration of airborne
particles. Note that the edges of the respirator are designed to form a seal
around the nose and mouth. Surgical N95 Respirators are commonly used in
healthcare settings and are a subset of N95 Filtering Facepiece Respirators
(FFRs), often referred to as N95s.

 General

N95 Respirator Precautions

• People with chronic respiratory, cardiac, or other medical conditions that make
  breathing difficult should check with their health care provider before
  using an N95 respirator because the N95 respirator can make it more
  difficult for the wearer to breathe.
• Some models have exhalation valves that can make breathing out easier and help reduce heat
  build-up. Note that N95 respirators with exhalation valves should not be
  used when sterile conditions are needed.
• All FDA-cleared N95 respirators are labeled as “single-use,” disposable devices. If
  your respirator is damaged or soiled, or if breathing becomes difficult,
  you should remove the respirator, discard it properly, and replace it with
  a new one. To safely discard your N95 respirator, place it in a plastic bag
  and put it in the trash. Wash your hands after handling the used
  respirator.
• N95 respirators are not designed for children or people with facial hair. Because a proper fit
  cannot be achieved on children and people with facial hair, the N95
  respirator may not provide full protection.

N95
Respirators in Industrial and Health Care Settings

Most N95 respirators are manufactured for use in construction and other industrial
type jobs that expose workers to dust and small particles. They are regulated
by the National Personal Protective Technology Laboratory (NPPTL) in the
National Institute for Occupational Safety and Health (NIOSH), which is part of
the Centers for Disease Control and Prevention (CDC).

However, some N95 respirators are intended for use in a health care setting.
Specifically, single-use, disposable respiratory protective devices used and
worn by health care personnel during procedures to protect both the patient and
health care personnel from the transfer of microorganisms, body fluids, and
particulate material. These surgical N95 respirators are class II devices
regulated by the FDA, under 21 CFR 878.4040, and CDC NIOSH under 42 CFR Part
84.

N95s respirators regulated under product code MSH are class II medical devices
exempt from 510(k) premarket notification, unless:

• The respirator is intended to prevent specific diseases or infections, or
• The respirator is labeled or otherwise represented as filtering surgical smoke or plumes,
  filtering specific amounts of viruses or bacteria, reducing the amount of
  and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or
• The respirator contains coating technologies unrelated to filtration (e.g., to reduce and or kill
  microorganisms).

The FDA has a Memorandum of
Understanding (MOU) with CDC NIOSH which outlines the framework
for coordination and collaboration between the FDA and NIOSH for regulation of
this subset of N95 respirators.

For additional differences between surgical masks and N95 respirators, please see CDC’s infographic.