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>> NIOSH Approved N95
respiratory protective devices are the most common type
of filtering facepiece respirator,
or FFR, used in U.S.
workplaces.
These disposable respirators
form a tight seal to the face,
removing particles such as bacteria,
viruses, and dust from the air
as you breathe through them.
The NIOSH
Respirator Approval
Program is responsible
for the testing and approval of respirators
intended to be used in occupational
settings.
For NIOSH to approve a respirator,
it must meet the requirements defined in the Code
of Federal Regulations.
These regulations
include requirements on quality assurance,
general construction, performance,
labeling,
packaging, and instructions.
Because NIOSH Approved respirators meet
these requirements, users can be confident
in the level of protection that the device provides
when it is worn and used correctly.
There are many other products
on the market that, sometimes falsely,
claim to be equal
to a NIOSH Approved N95 FFR.
Some even claim to be NIOSH
approved when they are not.
So how can you tell
if your N95 respirator is NIOSH approved?
Respirators
that have NIOSH approval
will have specific labeling
printed on the facepiece.
You may see some respiratory
protection products on the market
labeled as “N95.”
However,
if a product does not contain all the parts
of the required label,
it is not a NIOSH Approved respirator
and, therefore, has not been evaluated
according to NIOSH’s strict
testing requirements.
This means it may not provide the level of protection
it claims.
The required
labeling information on a NIOSH Approved N95 FFR appears
on the respirator facepiece
or strap itself.
This includes:
The name of the approval holder,
which will often be
the approval holder’s business
name or the private label
name of another company that is permitted to sell
the product under the same
approval number.
The part or model number.
The NIOSH filter series and filter
efficiency level of the respirator type,
which in this case would be “N95”.
The NIOSH approval number,
which is written as TC-84A-
and ends in four unique characters
and NIOSH in capital
block letters.
A lot number may
also be on the N95
abbreviated label.
If it is not found on
the FFR itself,
it will be on the product packaging.
The lot number is required
to be listed on the abbreviated label
for NIOSH Approved Surgical N95 respirators,
which are specifically meant
for use in healthcare.
If you’re still unsure
about whether your respiratory
protection product is a NIOSH Approved respirator,
you can use the information from the label
to search the NIOSH Certified Equipment List
to verify the specific
TC approval number and approval
holder or private label company.
This is the official listing
of NIOSH Approved respirators.
To search by the approval number,
type in 84A dash
and the four unique characters
printed on your respirator label.
If no results are found,
it means it is not a valid NIOSH approval number
and the product is not NIOSH
approved.
If you do not have the approval
number you can also search the list
by manufacturer name
or the private label,
found under the Advanced
Search tab.
NIOSH
also provides frequently
updated lists of all approved N95
FFRs by type and model
or part numbers,
which include the instructions describing
how to put the respirator
on correctly.
After using these tools to confirm
that your respirator is NIOSH approved,
you can be confident
that it is working as expected to protect you
as long as it is worn
and used correctly,
forms a tight seal to your face
without gaps, and maintained and replaced
as recommended by the manufacturer.
When demand for N95 FFRs is high,
the number of products
with false claims of NIOSH approval on the market
increases, either
through counterfeit respirators
or misrepresentation
of the NIOSH approval.
The respirator
classification “N95” and the term
“NIOSH Approved”,
are recorded with the U.S.
Patent and Trademark Office.
Any misuse of these marks, including on respirators
that have failed to satisfy NIOSH’s
regulatory requirements
or have not received
a NIOSH approval,
is a direct violation
of applicable trademark laws.
Counterfeit respirators are those
that have not successfully undergone
NIOSH testing and evaluation themselves
but were specifically manufactured to mimic
a respirator product
that did receive NIOSH approval.
Similarly, misrepresentation
of the NIOSH approval occurs when a product is falsely
marketed and sold as being approved
by NIOSH.
Because misrepresented and counterfeit
products are not NIOSH approved,
they may not provide
the expected level of protection.
At a glance, there are several clues
that you can look for to help identify
if your product is counterfeit
such as,
It does not include all
the required label markings.
NIOSH is spelled incorrectly.
It includes decorative fabric
or other add-ons like sequins.
It claims to be approved
for children.
(NIOSH does not approve
any type of respiratory protection
specifically for children.)
You can find more tips for spotting counterfeit
respirators on our webpage.
If you have concerns
about your respirator being counterfeit
or misrepresenting the NIOSH approval
or have questions
about NIOSH Approved respirators,
please email ppeconcerns@cdc.gov
More information is also available
on the NIOSH website.
To be confident
that your respirator is NIOSH approved, follow
the tips and resources provided
in this video.
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