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How to choose masks?

There are many types of masks around the world, which conform to different standards. Despite the name on the package, you should pay more attention to applicable standards.

Generally speaking, there are two categories of masks, medical masks and personal masks. Medical masks are class 2 medical devices in China, which need to be authorized by National Medical Products Administration (NEPA). Manufacturers need to get the production permit besides the business license. Medical Devices listing on NEPA are mandatory as well. However, there are no special permits for the manufacture of personal masks.

Medical Masks

Table 1.  Comparison of mask standards for medical use among China, US and EU.

 

Test

China

Typical Canada/US

EU

YY/T0969-2013

YY0469-2011

GB19083-2010

ASTM F2100

EN 14683

 Medical

Surgical

Medical KN95

Surgical, Procedure,Medical

Surgical, Procedure,Medical

L1

L2

L3

TypeI

TypeII

TypeIIR

Bacterial Filtration Efficiency, %

≥95

≥95

-

≥95

≥95

≥98

≥95

≥95

≥98

Delta P, Differential Pressure

<5.0

<5.0

Airflow Resistance

<4.0

<5.0

<5.0

<3.0

<3.0

<5.0

mm H2O/cm2 (Pa/cm2)

<49.0

<49.0

<35mm H2O

<39.2

<49.0

<49.0

<29.4

<29.4

<49.0

Submicron particulate filtration efficiency at 0.1 micron, %

-

≥30

class1>95

≥95

≥98

≥98

-

-

-

calss2>99

class3>99.97

Splash Resistance/Synthetic Blood Resistance, mmHg

-

120

80

80

120

160

-

-

120

Flame Spread

-

Non-flammable

Non-flammable

Class 1

Class 1

Class 1

-

-

-

The table 1 shows the comparison of mask standards for medical use among China, US and EU. The masks for medical use in China are designed specifically for different purpose of use, while all level of ASTM F2100 masks have slight difference in specification. In EU, the requirements of EN 14683 Type I and Type II are lower than China and US, Type IIR is the equivalent to YY0469-2011 and ASTMF2100 level2.

Personal Masks

Table 2. Comparison of mask standards for personal use among China, US and EU

 

Test

China

Typical Canada/US

EU

GB/T32610-2016

GB2626-2006

NIOSH:42 CFR Part 84

EN 14683

Face mask

KN series Mask

N Series Mask

FFP Series mask

class1

class2

class3

KN

N95

FFP2

Nonoi submicron particulate filtration efficiency at 0.1 micron, %

≥99

≥95

≥90

 KN95:≥95 

 N95: ≥95 

FFP2: ≥94

Oil-based submicron particulate filtration efficiency at 0.2 micron, %

≥99

≥95

≥80

-

 

FFP2: ≥94

Inhalation Resistance,Pa

≤175

≤ 350

≤ 343

≤ 240

Exhalation Resistance, Pa

≤145

≤ 250

≤ 245

≤300

The table 2 shows the comparison of typical mask standards for personal use among China, US and EU.  Masks that conforms to GB/T32610-2016 are designed for daily protection from PM2.5. Most masks you find on the market shelf are this type. Prices will vary hugely depend on the protective grade.

A reference by 3M in a technical bulletin released in January 2020 demonstrates that China KN95 is “equivalent” to US NIOSH N95 and European FFP2 respirators, for filtering non-oil-based particles such as those resulting from wildfires, PM 2.5 air pollution, volcanic eruptions, or bioaerosols (e.g. viruses).

FDA issued a new EUA (Emergency Use Authorization) for non-NIOSH-approved N95 respirators made in China, which makes KN95 respirators eligible for authorization if certain criteria are met.

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