Medical Equipments – Kim Duc Group

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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	Link
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
		Breathability: 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

Certifications

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)

Isolation

With full back coverage

4 critical area protection

Surgical

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

Certification (TBA 2021)

FFP2

EU Examination by Notified body APAVE NB0082

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

USA

N95 Surgical mask

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