What is a N95 N99 N100 facemask/respirator? What is the label requirements for N95?

N95 Mask label requirements

NIOSH-Approved N95 Respirators

Particulate respirators are designed to reduce the wearer’s exposure to airborne particulate hazards.  In the U.S., respirators are tested and certified by the U.S. National Institute of Occupational Safety and Health (NIOSH).

NIOSH tests and certifies respirators based on their physical and performance characteristics, including filtration efficiency. N95-rated filtering facepiece respirators have a filtration efficiency of at least 95% against non-oily particles when tested using the NIOSH criteria. 

 

9 Standards for N95 from NIOSH

There are a total of nine standards by the National Institute for Occupational Safety and Health (NIOSH): Combine 3 types of oil-resistant initials and 3 types of performance figures.

95 99 100
N N95 N99 N100
R R95 R99 R100
P P95 P99 P100

 

  • N: Not resistant to oil
  • R: Resistant to oil
  • P: Oil Proof (with oil resistance)
  • N95 / R95 / P95: Performance that can remove 95% or more of fine particles of 0.1 to 0.3 µm
  • N99 / R99 / P99: Performance that can remove 99% or more of fine particles of 0.1 to 0.3 µm
  • N100 / R100 / P100: Performance that can remove 99.97% or more of fine particles of 0.1 to 0.3 µm

Who is NIOSH?

The National Institute for Occupational Safety and Health (referred to as NIOSH) is an American country a federal agency responsible for work-related injuries and illnesses to study and to provide prevention advice. NIOSH is affiliated with the Centers for Disease Control and Prevention (CDC) of the U.S. Department of Health and Human Services .

NIOSH is headquartered in Washington, DC , in Ohio, Cincinnati , West Virginia State Morgantown , Pennsylvania, Pittsburgh , Colorado State Denver , Alaska Ankeleiqi , Washington, Spokane and Georgia Atlanta has its research Laboratory and office [1] . NIOSH is a multi-disciplinary organization with more than 1,400 employees. They represent multiple industries, including epidemiology, medicine, industrial hygiene, safety, psychology, engineering, chemistry, and statistics. The current head of NIOSH is John Howard.

On December 29, 1970, President Richard Nixon signed the “Occupational Safety and Health Regulations” and established NIOSH and the Occupational Safety and Health Administration (OSHA). NIOSH was created to help ensure safe and hygienic working conditions by providing research, information, education and training in the field of occupational safety and health. NIOSH provides national and world-leading measures to prevent work-related diseases, injuries, disabilities, and deaths by collecting information, conducting scientific research, and transforming information in products and services. [2]

What is OSHA?

 

Label Requirements for N95 Masks

An authentic N95 respirator is marked with the text “NIOSH” or the NIOSH logo, the filter class (“N95”), a “TC” approval number of the form XXX-XXXX, the approval number must be listed on the NIOSH Certified Equipment List (CEL) or the NIOSH Trusted-Source page, and it must have headbands instead of ear loops.  Check out the below identification picture from CDC for references.   [1]

  • Approval holder business name – a registered trademark or an easily understood abbreviation.If privately labeled, the private label name or logo will appear instead of the approval holder business name.
  • NIOSH -NIOSH name in block letters or NIOSH logo
  • TC-Approval Number (TC-84A-XXXX)– For products manufactured after September 2008, the TC-Approval number is required to appear on the product.
  • Filter Designation – NIOSH filter series. Alphanumerical rating followed by filter efficiency level (example, N95, N99, N 100, R95, P95, P99, P100) 
  • Lot# XXXX-Lot Number and Date of Manufacture (recommended, but not required) 
  • Model# XXXX-Model Number or Part Number

N95 Label Requirements

Reference:

  1. Approved Particulate Filtering Facepiece Respirators | NPPTL | NIOSH | CDC. (n.d.). CDC. https://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/default.html
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