Medical Equipments

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Construction Community usage Medical usage
Outer layer Non-woven fiber (30gsm)
Dust and micro-particle filter Meltblown filter

BFE > 95%

Meltblown filter

BFE > 98%

Sweat-absorbing layer Non woven fiber (30gsm)
Additional service Advice on labelling in compliance with US & EU requirements
Kim Duc profile
FDA Mask registration FDA Registration / CFS
CE Declaration of Conformity Link A – self issue

Link B – issued by a 3rd party

Test for Disposable mask

EN 14683 Type I

ASTM F2100 Level 1 & 2

FDA Guidance For face mask & surgical mask: Link

Full guidance: Link

Certification Quality Notes
KIM DUC Tested Requirement
Disposable Mask

For community usage, source control

USA: FDA Operator number 10074394

EU: CE Declaration of Conformity

ASTM 2100 – level 1

EN 14683 – Type I

Bacterial Filtration Efficiency: 99.83% BFE >95% Filter material: Will be used for all Disposable Mask models
Splash Resistance: 80mmHg & 120mmHg 80mmHg Outer layer material: Will be used for all Disposable Mask models

4.6 mm H2O/cm2

< 5 mmH2O/cm2

Or <40 Pa/cm2

Surgical mask

For medical procedures

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

Tests & import capability to USA: TBA December

510(k): TBA first quarter of 2021

Kim Duc profile
FDA gown registration FDA Registration / CFS
Test for PP non-woven with PE lamination gown Link
Test for Breathable SMS non-woven gown Link
Material Weight Construction
PP non-woven with lamination 45gsm – Ultrasonic sewing

– Neck tie

– Belt in back

– Elastic sleeve end

– Full back coverage

=> critical areas tested

– Can add tricot cuffs on requests

Breathable SMS non-woven 40gsm
USA AAMI PB70 Level 2

– Spray impact penetration <1.0g

Hydrostatic pressure >20cm

– Moderate protection

Suitable for general usage & health care personnel, offer minimum protection against low to medium- level threat.
Models Illustration (back)

With full back coverage

4 critical area protection


Tie in back

3 critical area protection

Construction – 5 layers
Water-resistance layer 2 x Non-woven fabric
Dust and micro-particle filter 2 x Meltblown layer
Support layer 1 x Heatseal cotton layer
Pcs per box 30
Size of box (cm) 21L x 15W x 10H
Box per carton 50
Size of carton (cm) 76.5L x 43.5W x 52H
Certification (TBA 2021)


EU Examination by Notified body APAVE NB0082

Under PPE Regulation 2016/425 PPE-R/02.075 version 2


N95 Surgical mask

To be Approved to distribute in the USA under the Emergency Use Authorization released by FDA