N95, FFP2, KN95, P2, KF94, and DS2 — What is the difference between these respirators and masks?

N95, FFP2, KN95, P2, KF94 and DS2 — What’s the difference?

With more severe COVID-19 variants emerging and spreading to different countries worldwide, people are feeling the need for extra protection. If you’re reading this, you must know there’s a growing interest in N95 masks and other types of face masks again. With so many different types of face masks on the market to choose from, which one is the right one for you? Most people don’t realize that different countries have different standards for these respirators. We’re here to give you a quick comparison and clarify the key differences! [1]:

 

Certification/
Class
(Standard) N95
(NIOSH-42CFR84) FFP2
(EN 149-2001) KN95
(GB2626-20 06) P2
(AS/NZ 1716:2012) KF94 (KMOEL – 2017-64) DS2 (Japan JMHLW-
Notification 214, 2018) Filter performance –
must be ≥ X% efficient ≥ 95% ≥ 94% ≥ 95% ≥ 94% ≥ 94% ≥ 95% Test agent NaCl NaCl and paraffin oil NaCl NaCl NaCl and paraffin oil NaCl Total inward leakage (TIL)*
– tested on human subjects each performing exercises N/A ≤ 8% leakage (arithmetic mean) ≤ 8% leakage (arithmetic mean) ≤ 8% leakage (individual & arithmetic mean) ≤ 8% leakage (arithmetic mean) Inward Leakage measured and included in User Instructions Inhalation resistance – max pressure drop ≤ 343 Pa ≤ 70 Pa (at 30 L/min)
≤ 240 Pa (at 95 L/min)
≤ 500 Pa (clogging) ≤ 350 Pa ≤ 70 Pa (at 30 L/min)
≤ 240 Pa (at 95 L/min) ≤ 70 Pa (at 30 L/min)
≤ 240 Pa (at 95 L/min) ≤ 70 Pa (w/valve)
≤ 50 Pa (no valve) Flow rate 85 L/min Varied – see above 85 L/min Varied – see above Varied – see above 40 L/min Exhalation resistance – max pressure drop ≤ 245 Pa ≤ 300 Pa ≤ 250 Pa ≤ 120 Pa ≤ 300 Pa ≤ 70 Pa (w/valve)
≤ 50 Pa (no valve) Flow rate 85 L/min 160 L/min 85 L/min 85 L/min 160 L/min 40 L/min Exhalation valve leakage requirement Leak rate ≤ 30 mL/min N/A Depressurization to Pa ≥ 20 sec Leak rate ≤ 30 mL/min visual inspection after 300 L /min for 30 sec Depressurization to Pa ≥ 15 sec Force applied -245 Pa N/A -1180 Pa -250 Pa N/A -1,470 Pa CO2 clearance requirement N/A ≤ 1% ≤ 1% ≤ 1% ≤ 1% ≤ 1% *Japan JMHLW-Notification 214 requires an Inward Leakage test rather than a TIL test.

United States: N95

N95 is one of the standards of respirators named by the National Institute for Occupational Safety and Health (NIOSH). There are actually a total of nine standards currently, combining 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

Now, where do the rest of the masks stand in comparison to N95?

Europe uses both EN 149 and EN 143 standards for their FFP2 masks. The “filtering facepiece” score (FFP) comes from EN standard 149:2001, while EN 143 standard covers P1, P2 & P3 ratings for the product strength. Both standards are maintained by CEN (European Committee for Standardization) [2]:

• P1 (80% filtering)
• P2 (94% filtering)
• P3 (99% filtering)

Both EN 143 and EN 149 test the penetration of filters with dry aerosols containing sodium chloride (NaCl) and paraffin oil after storing the filters at 70 °C and -30 °C for 24 hours each. Standards include mechanical strength, breathing resistance, and obstruction tests.

EN 149 tests leakage between mask and face, where 10 human subjects perform 5 exercises each, and for 8 individuals the measured average leakage should not exceed 22%, 8%, and 2% respectively.

According to EN 149:2001, FFP2 masks filters 94% of particles and are similar to N95 masks in non-oily particle filtration. The higher standard FFP3 (high-efficiency filter masks) can filter 99% of particles. However, EN and NIOSH standards are slightly different as the EN standard requires both oily (paraffin oil mist) and non-oily (sodium chloride) particles to be filtered at the same time.

In addition, suffixes are often added to the label of FFP2/3 masks, such as “R” for reusable, “NR” for non-reusable, and “D” for passing the dolomite obstruction test. [3]

US & EU Standards Comparison:

Respirator Standard Filter Capacity (removes x% of all particles that are 0.3 microns in diameter or larger) FFP1 & P1 At least 80% FFP2 & P2 At least 94% N95 At least 95% N99 & FFP3 At least 99% P3 At least 99.95% N100 At least 99.97%

Australia: P2

In Australia, masks similar to N95 are called P2 masks. P2 masks have a few different testing methods compared with the N95 masks.

The aerosol flow

There are some minor differences in the aerosol flow rates and particle sizes that both these masks protect against.

P2 filter has efficiency of 94% and  N95 filter has efficiency of 95%

Besides the 1% difference infiltration, there are some other small differences in other factors.

The exhalation resistance

The exhalation resistance of P2 masks is lower than the N95 masks. [4]

Australia requires manufacturers to test their masks for “CO2 clearance,” which prevents CO2 from building up inside the mask. In contrast, N95 masks don’t have this requirement.

Although CO2 buildup can be a scary issue for the public, studies have found there is no reason to worry about blood oxygen levels. One study in particular indicated that during moderate exercise, women wearing N95 masks had no change in blood oxygen levels, even while pregnant! [5]

N95 and P2 masks are nearly identical on filtration–the factor most people care about. However, there are small differences in other factors, such as breathing resistance and requirements for fit-testing.

Japan: DS2

There are two types of masks in the Japanese standard that works similar to the N95 mask. The filtration standards are the same as N95 masks [6], except RS2 is reusable.

• DS2: disposable masks
• RS2: reusable masks

Mainland China: KN95 mask

Both KN95 & N95 masks are made from several synthetic material layers and are intended to be worn over the mouth and nose. Both filter out 95 percent of aerosol particles that could potentially be carrying the novel coronavirus. Authentic KN95 respirators can provide equivalent protection to an N95 mask.

So, what is the difference between an N95 and a KN95 mask?

N95 is the only standard that has been approved by the National Institute for Occupational Safety and Health (NIOSH), the U.S. organization responsible for regulating face masks and respirators.

In September 2020, ECRI conducted a review test for KN95 masks, and discovered that nearly 70% of those produced in China did not meet the NIOSH filtering requirements.  [7]

South Korea: KF94

>The Korean standards refers to its Food and Drug Administration (MFDS). The “KF” stands for “Korean Filter,” and “94” represents the filtration efficiency, which indicates how good the mask is at filtering out particles. However, not to confuse the Korean standard with the US standard:

• KF94: Korean standard, which means that the filtration rate of masks for particles with an average diameter of 0.4μm is greater than 94%.

Whereas N95, states that the mask can filter more than 95% of non-oily particles with a diameter of 0.3μm.

In Conclusion…

Besides the difference in quality filtering properties of the masks, it is still important to note that no masks are effective unless worn properly. It is critical for healthcare workers and those who are at risk or have been in contact with confirmed COVID-19 patients to make sure they are well protected.

Have you decided what mask is right for you? Check out Medtecs’ N95 masks for more!

References