Regulatory and standard information American buyers need to know when importing respirators (N95)

Face masks used for protection during the Coronavirus pandemic, and in any healthcare setting, belong to the product category of ‘disposable medical PPE. We can generally categorize PPE face masks 3 ways:

1.Surgical face mask (medical face mask) – vary from 3 to 5 ply thickness

2.N95 Respirators – vary based on oil-resistance and filtration percentage

3.Regulations common to both Medical Face Masks and Respirators

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N95 respirator manufacturer

      Respirators (N95) For Medical Use

According to the FDA:

An N95 [standard] respirator is a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles.

They are a type of Filtering Face piece Respirator (FFR). Respirators do a similar job as medical masks, but in addition they protect the wearer from very small particles.

N95 respirator manufacturer

A well-known label for them is ‘N95’ masks and they are so-called because their standard is to filter out 95% of 0.3 µm particles. However, ‘N’ is not the only designation.

In fact, we can see the following:

  • N= Not oil-resistant
  • R= somewhat oil-Resistant
  • P= oil-Proof
  • 95= 95% efficiency at 0.3 µm
  • 99= 99% efficiency at 0.3 µm
  • 100= 99.97% efficiency at 0.3 µm (this rating is equivalent to the HEPA filters used on products such as vacuum cleaners and air filtering machines or in automobiles).

In a healthcare setting, non oil-resistant masks are usually used, hence the focus on ‘N’ respirators during this pandemic.

 

FDA regulated under 21 CFR 878.4040

Like surgical masks, they are also FDA regulated under 21 CFR 878.4040 as class II medical devices (see part 3) because, in the case of respirators used specifically to protect against coronavirus, they are not exempt (respirators not used for health reasons will be exempt from 21 CFR 878.4040). So importers will be expected to provide detailed information about:

  • Identification
  • Classification
  • Analysis and Non-clinical testing (tests shown earlier)
  • Usability performance
  • Labeling requirements
  • Warning and precautions
  • N95 respirator manufacturer

Standards & Lab Tests specific to respirators: NIOSH and OSHA requirements

NIOSH

The difference between surgical masks and respirator production are the testing standards they must adhere to which fall under NIOSH, 42 CFR Part 84 Respiratory Protective Devices standard:

As per 42 CFR: “NIOSH will now have exclusive authority for testing and certification of respirators with the exception of certain mine emergency devices, which will continue to be jointly certified by NIOSH and MSHA.”

42 CFR 84 subpart K for Non-Powered Air-Purifying Particulate Respirators 

42 CFR 84 demands the following before approval can be granted:

  • Labeling
  • QC plans
  • Description
  • Required components
  • Inhalation and exhalation valve minimum requirements
  • Head harnesses; minimum requirements
  • Filter identification
  • (Test 1) Airflow resistance tests
  • (Test 2) Non-powered air-purifying particulate filter efficiency level determination
  • (Test 3) Exhalation valve leakage test

Respirator Lab Tests

There are three tests that need to be performed to meet testing requirements.

  • (Test 1) Airflow resistance tests
    The Inhalation and Exhalation Resistance testing is conducted to measure the breathability of the respirator. For NIOSH acceptance, the inhalation resistance cannot exceed 35 mm water column height pressure. For NIOSH acceptance, the exhalation resistance cannot exceed 25 mm water column height pressure.
  • (Test 2) Non-powered air-purifying particulate filter efficiency level determination
    The Sodium Chloride Aerosol testing is conducted to determine the percentage of particles filtered by the respirator. ≥95% filtration efficiency for N95 respirators.
  • (Test 3) Exhalation valve leakage test
    The Valve Leakage testing measures the amount of leakage between the valve and the valve seat. For NIOSH acceptance, the leakage between the valve and the valve seat cannot exceed 30 milliliters per minute.
  • N95 respirator manufacturer

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Watch this video about respirator certification from NIOSH: Respirator Certification – As Vital as the Air We Breathe

OSHA

It’s also useful for importers to understand how respirators are regulated by the Occupational Safety and Health Administration standard number 1910.134 – Respiratory Protection. This will show how employees in the USA who are exposed to airborne dangers should be equipped with a NIOSH-certified respirator to protect them by their employers.

 

Surgical N95 respirators are exempt from the 501(k) premarket notification if they are NIOSH (National Institute for Occupational Safety and Health) approved.

 

How does respirator filtration work?

This video from NIOSH can help explain mask filtration (especially in the case of N95 masks): A Particle is a Particle

Particles are trapped by masks in 3 ways:

  1. Impaction
  2. Interception
  3. Diffusion

N95 respirator manufacturer

Physics dictates that 0.3 µm is the particle size which can pass most easily through materials like masks, they are just the right size to be small enough but have enough velocity. Therefore mask filtration is based on that size.

Larger sized particles are too large and will be trapped, and, perhaps surprisingly, smaller sized particles will also become trapped (filtered) as they are too small to have enough velocity to make it through the material.

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