CE 0370 And FDA Disposable Nonwoven Face Mask Particulate Respirator , FFP2 Protective Respirator With Earloops
Nonwoven FFP2 Face Mask , FFP2 Particulate Respirator Mask, FFP2 Protective Respirator With Earloops ,CE 0370 and FDA
Key Specifications/Special Features:
- • CE 0370, FDA;
- • China Mask White List Exporter ;
- • EUA Authorized Factory by USA FDA;
- • Single Piece Pack or 10 Pcs Pack , 50 Pcs /Box, 1500 Pcs/Carton;
- • Excellent Filtration efficiency against Non-Oil and Oil Particulates;
- • Total 5 Layers;
- •High Quality Packing Box with Internal and External Cover, Excellent Packing Design and Presentation;
- •Packing Box and Polybag with Different Global EAN Barcodes,
- •MFG Date , EXP. Date & LOT No. Actively Printed on Packing Box ;
Packing Specifications:
-
Option A:
Single pack, 50pcs / Box
30 Boxes / Carton , 1500pcs /Carton
【Box】15.5cmX12cmX20cm
【Carton 】62cm X 48.5cm X 42cm
【NW】around 12KG/carton
【GW】around 13KG/Caron
【Container】
40 Feet HQ loads 515 cartons = 772500 Pcs
-
Option B:
10 Pcs / Pack , 5 Packs x 10 Pcs /Box, 50pcs / Box
30 Boxes / Carton , 1500pcs /Carton
【Box】14 cmX12cmX 17.5 cm
【Carton 】62cm X 44cm X 37cm
【NW】around 10KG/carton
【GW】around 11KG/Caron
【Container】40 Feet HQ loads 679 Cartons = 1018500 Pcs
Competitive Advantage:
≥94% Filtration efficiency against Non-Oil and Oil Particulates; In conformity with FFP2 NR under EU Standard;
High Quality Packing Box with Double Cover, Meeting All Requirements of EN 149:2001+ A1 :2009, FFP2
Manufacturing Date and Expiration Date are Actively Printed on the Box; Latex-Free;High Breathability ;Skin Friendly Materials;
Specially Designed Shape and Ultra-Comfort Materials; Elastic and Firm Earloops;
Two Layers of Meltblown Fabric 50pcs / Box , 1500 Pcs /Carton
Optional Packing : Single Pack , Customized Packing Language,Global EAN Bar Code on Packing Box
Certifications and Qualifications:
CE 0370 Module B Certificate - 1/2 of 2
CE 0370 Module C2 Certificate - 1/2 of 2
Frequently Asked Questions :
Question:
We have Heard Quite Much About Type I, Type II, and Type IIR Face Mask. What Are Exactly Type I , Type II, Type IIR About ?
Answer :
According to European Standard, EN 14683:2019 +AC : 2019, Medical face masks specified in this European Standard are classified into two types (Type I and Type II) according to bacterial filtration efficiency whereby Type II is further divided according to whether or not the mask is splash resistant. The 'R' signifies splash resistance.
Type I : Bacterial filtration efficiency (BFE) ≥ 95
Type II: Bacterial filtration efficiency (BFE) ≥ 98
Type IIR: Bacterial filtration efficiency (BFE) ≥ 98, with splash resistance.
The following Table can indicate clearly on the performance requirements of Type I, Type II and Type IIR. Type II can be used for medical settings, Type IIR Face Masks are used as surgical environments since it's Splash resistance has mandatory requirements.
Table — Performance Requirements For Medical Face Masks (EN 14683:2019 +AC:2019)
|
Test |
Type I a | Type II |
Type IIR
|
| Bacterial filtration efficiency (BFE), (%) | ≥ 95 | ≥ 98 | ≥ 98 |
|
Differential pressure (Pa/cm2) |
< 40 |
< 40 |
< 60 |
| Splash resistance pressure (kPa) | Not required | Not required | ≥ 16.0 |
| Microbial cleanliness (cfu/g) | ≤ 30 | ≤ 30 | ≤ 30 |
| a Type I medical face masks should only be used for patients and other persons to reduce the risk of spread of infections particularly in epidemic or pandemic situations. Type I masks are not intended for use by healthcare professionals in an operating room or in other medical settings with similar requirements. | |||
To Get More Information About the EU Medical Face Masks Standard
Download EU Medical Face Masks Standard : EN 14683 : 2019 + AC : 2019
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