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FREQUENTLY ASKED QUESTIONS

You asked... We answered...


We take all the complex relevant information and simplify it for you to understand

 

WHAT IS THE ROLE OF THE FDA IN MASK APPROVAL?

The FDA observes sales and marketing of all surgical masks and evaluates masks in four areas of performance, including: fluid resistance, differential pressure, filter efficiency and flammability. 

These four areas of interest by the FDA are based on ASTM standards (American Society of Testing and Materials). Specifications and criteria by the ASTM are accepted as the industry standard. Beware of masks that do not follow these standards!

WHAT IS THE ROLE OF NIOSH IN MASK APPROVAL?

Respirators used in the workplace of the United States must be approved by the National Institute for Occupational Safety and Health (NIOSH) and meet the standards and test results designed by regulations (42 Code of Federal Regulations, Part 84).


95% is the minimal level of filtration approved by NIOSH. 

N, R and P designations refer to the respirator filter's oil resistance.

WHAT IS THE ROLE OF THE CDC IN MASK APPROVAL?

The Center for Disease Control (CDC) functions to perform scientific research and provide health information. The CDC is headquartered in Atlanta, Georgia and is a national public health institute in the United States.

The CDC functions to conduct important research and scientific studies to convey information to the public in order to protect people. They do not classify or certify masks themselves, but  they recommend precautionary measures and produce data to minimize the impact of various diseases.

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SURGICAL MASKS

Evaluation, Testing & Certification

Surgical mask manufacturers provide data and claims to the FDA in the United States.

FDA reviews the data submitted by manufacturers and compares performance to other masks already cleared by the FDA.


Purpose

Barrier to splashes, droplets and saliva.

Face fit

Not designed to seal tight against the face.

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RESPIRATORS

Evaluation, Testing & Certification

Evaluated, tested and certified by NIOSH to meet minimum performance requirements.


Purpose

Protect from exposure to airborne particles (e.g. viruses).

Face fit

Designed to seal TIGHTLY to the face.

 

THERE ARE THREE DIFFERENT TYPES OF RESPIRATORS

(1) Disposable particulate filtering face piece respirators (example: N95s)

(2) Elastomeric respirators which are reusable respirators that have a replaceable filter

(3) Powered air-purifying air respirators (PAPRs) in which air moves through filters by a battery powered fan

 

MASKS ARE TESTED BY FOUR FACTORS FOR FDA APPROVAL

FLUID RESISTANCE

FILTER EFFICIENCY

DIFFERENTIAL PRESSURE

FLAMMABILITY

Image by Adrien Ledoux
 

What are the differences between masks that are level 1, 2 and 3?

The different "mask levels" refer to their degree of protection. Level 1 is a lower degree of protection compared to level 3, which is the highest level of protection given by a mask.

Masks are rated based on their ability to resist fluid penetration at a certain pressure, their difficulty of breathability and their ability to stop (filter) small particles from penetrating the mask.

Level 1 (low protection)

- light/minimum protection

- used in general procedures and respiratory etiquette

- designed to resist the splash or spray at the low pressure found in veins of 80 mm Hg


- bacterial filtration efficiency (BFE) at 3.0 micron greater than 95%

- particulate filtration efficiency (PFE) at 0.1 micron greater than 95%

Level 2 (moderate protection)

- high bacterial filtration efficiency (BFE) and high particulate filtration efficiency (PFE)

- more breathable than high barrier mask

- designed to resist splash or spray at the high pressure found in arteries of 120 mm Hg


- bacterial filtration efficiency (BFE) at 3.0 micron greater than 98%

- particulate filtration efficiency (PFE) at 0.1 micron greater than 98%


Level 3 (high protection)

- high BFE and PFE protection

- highest fluid resistance to resist strong spray during trauma surgery with a high pressure of 160 mm Hg


- bacterial filtration efficiency (BFE) at 3.0 micron greater than 98%

- particulate filtration efficiency (PFE) at 0.1 micron greater than 98%

 
Image by Julian Wan

WHY IS IT IMPORTANT TO HAVE A MASK THAT FITS PROPERLY? HOW SHOULD A MASK BE WORN?

A MASK IS ONLY AS EFFECTIVE AS ITS FIT

A well-fitting mask stays in place over nose and cheeks. IT SHOULD ALWAYS COVER THE MOUTH AND NOSE. Ideally, there should be no gaps along the sides of the face, around the nose, nor under the chin. This proper fit allows air and droplets to pass through the filter (i.e. the mask material), thereby protecting the wearer from particles and droplets that may contain a virus.