Medical Equipments

For distribution in Vietnam only. Please stand by for our CE-marked & FDA approved products. Chỉ lưu hành tại Việt Nam. Chúng tôi sẽ thông tin đến quý khách về dòng sản phẩm có chứng nhận CE và FDA sau

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
Packing
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

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