×
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Construction
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Community usage
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Medical usage
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Outer layer
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Non-woven fiber (30gsm)
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Dust and micro-particle filter
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Meltblown filter
BFE > 95%
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Meltblown filter
BFE > 98%
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Sweat-absorbing layer
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Non woven fiber (30gsm)
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Additional service
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Advice on labelling in compliance with US and EU requirements
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Certification
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Quality
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Notes
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KIM DUC Tested
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Requirement
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Disposable Mask
For community usage, source control
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USA: FDA Operator number 10074394
EU: CE Declaration of Conformity
ASTM 2100 – level 1
EN 14683 – Type I
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Bacterial Filtration Efficiency: 99.83%
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BFE >95%
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Filter material: Will be used for all Disposable Mask models
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Splash Resistance: 80mmHg and 120mmHg
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80mmHg
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Outer layer material: Will be used for all Disposable Mask models
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Breathability:
4.6 mm H2O/cm2
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< 5 mmH2O/cm2
Or <40 Pa/cm2
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Surgical mask
For medical procedures
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USA: Test by Eurofins
ASTM 2100 – level 3
Liquid barrier protection level 2
EU: Test by a Notified body lab (CENTEXBEL NB 0493)
MDD 93/42/EEC
Type IIR
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Tests andimport capability to USA: TBA December
510(k): TBA first quarter of 2021
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