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Medical Protection Products




FPPD2/FPPD3/KN95/N95 Mask

Type: earloop disposable face mask
Size: 17.5*9.5 cm
Materials: Non woven cloth + Meltblown filter cloth +Non woven cloth
1st layer: leak proof non-woven fabric
2nd layer: high density meltblown filter cloth
3rd layer: direct skin contact non-woven layer
Stock Status: In Stock
Package: 50 pcs in a box, 40 boxes in a carton
Gross weight: 10 KGS per CTN
CTN Size: 52*38*30cm




What are the N95, KNP5, FFP2, P2 ?
Filtering facepiece respirators (FFR), which are sometimes called disposable respirators, are subject to various regulatory
standards around the world. These standards specify certain required physical properties and performance characteristics in
order for respirators to claim compliance with the particular standard. During pandemic or emergency situations, health
authorities often reference these standards when making respirator recommendations, stating, for example, that certain
populations should use an “N95, FFP2, or equivalent” respirator.
This document is only intended to help clarify some key similarities between such references, specifically to the following FFR
performance standards:
• N95 (United States NIOSH-42CFR84)
• FFP2 (Europe EN 149-2001)
• KN95 (China GB2626-2006)
• P2 (Australia/New Zealand AS/NZA 1716:2012)
• Korea 1st class (Korea KMOEL - 2017-64)
• DS (Japan JMHLW-Notification 214, 2018)
As shown in the following summary table, respirators certified as meeting these standards can be expected to function very
similarly to one another, based on the performance requirements stated in the standards and confirmed during conformity
testing.
One notable comparison point is the flow rates specified by these standards for the inhalation and exhalation resistance
tests. Inhalation resistance testing flow rates range from 40 to 160L/min. Exhalation resistance testing flow rates range from
30 to 95 L/min. Some countries require testing to be performed at multiple flow rates, others at only the high or low end of
those ranges. Although this appears to suggest that the standards’ requirements for breathing resistance (also called “pressure
drop”) differ from each other, it’s important to understand that pressure drop across any filter will naturally be higher at
higher flow rates and lower at lower flow rates. Given typical pressure curves for respirator filters, the standards’ various
pressure drop requirements are actually quite similar. This chart shows a representative filter pressure drop curve. If one
filter is tested at a high flow rate, the pressure drop performance will be relatively high. If that same filter is tested at a low
flow rate, the pressure drop performance will be relatively.


Different face mask standards in the world currently:
N95 (United States NIOSH-42CFR84)
FFP2 (Europe EN149-2001)
KN95 (ChinaGB2626-2006)
P2 (Australia/New Zealand AS/NZA1716:2012)
Korea 1st class (Korea KMOEL -2017-64)
DS (Japan JMHLW-Notification 214,2018)
What does these standards stand for ?
 

Certification/ Class (Standard)

 N95 (NIOSH-42C

FR84)

 FFP2 (EN 149-2001) KN95 (GB2626-20 06)  

P2 (AS/NZ 1716:2012)

Korea 1st Class (KMOEL – 2017-64) DS (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
Flow rate 85 L/min 95 L/min 85 L/min 95 L/min 95 L/min 85 L/min
Total inward leakage (TIL)* – tested on human subjects each performing exercises N/A ≤ 8% leakage (arithmetic mean) ≤ 8% leakage (arithmetic mean) ≤ 8% leakage (individual and 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 Depressurizatio n to 0 Pa ≥ 20 sec Leak rate ≤ 30 mL/min visual inspection after 300 L /min for 30 sec Depressurizatio n to 0 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%

Mask Codes:

Country Funtion Stardard Description
CHINA MEDICAL USE YY/T0969-2013 Disposable medical mask (HOSPITAL USE)
YY0469-2011 Medical Surgical Mask (HOSPITAL USE)
GB190832010 Medical Protetive Mask (HOSPITAL USE)
NO MEDICAL USE GB7132010-2016 Normal Protective Mask
GB2626-2006 Self-suction filter anti-particulate mask
EUROPEAN COUNTRIES MEDICAL USE EN14683:2014 Medical Surgical Mask Disposable medical mask Medical Protetive Mask (HOSPITAL USE)
NO MEDICAL USE EN149-2001+A1:2009 Self-suction filter anti-particulate mask
USA MEDICAL USE ASTM F20100:19 Medical Surgical Mask Disposable medical mask Medical Protetive Mask (HOSPITAL USE)
NO MEDICAL USE CFR 42-84-1995 Self-suction filter anti-particulate mask
JAPAN MEDICAL USE ASTM F2100-19 EN149-2001+A1:2009 Disposable medical mask Medical Protetive Mask (HOSPITAL USE)
EN14683:2014 Medical Surgical Mask (HOSPITAL USE)
NO MEDICAL USE JIS T8151:2018 Dust mask
AUSTRIA MEDICAL USE AS 4381:2015 Medical Surgical Mask Disposable medical mask Medical Protetive Mask (HOSPITAL USE)
NO MEDICAL USE AS/NZS 1716:2012 Self-suction filter anti-particulate mask
AS/NZS 1715:2009 respiratory protection devices
KOREA MEDICAL USE MFDS Notice No.2015-69
KS K ISO 22609:2018 Anti-infectious disease Protective clothing and Medical Surgical Mask Disposable medical mask Medical Protetive Mask (HOSPITAL USE)
NO MEDICAL USE KS M 6673:2008 respiratory protection devices





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