Disposable FDA 510k Face Mask

Product Details
Customization: Available
Type: Surgical Supplies Materials
Material: Non-woven Fabric
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Management System Certification
ISO 13485
Export Year
2006-05-15
  • Disposable FDA 510k Face Mask
  • Disposable FDA 510k Face Mask
  • Disposable FDA 510k Face Mask
  • Disposable FDA 510k Face Mask
  • Disposable FDA 510k Face Mask
  • Disposable FDA 510k Face Mask
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  • Overview
  • Product Description
  • Detailed Photos
  • Product Feature
  • Certifications
  • Packaging & Shipping
  • FAQ
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Overview

Basic Info.

Model NO.
WELLMIEN-FM006
Ethylene Oxide Sterilization
Without Ethylene Oxide Sterilization
Quality Guarantee Period
Three Years
Group
Adult or Children
Logo Printing
With Logo Printing
Color
Blue,White,Green,Pink
Size
17.5*9.5cm
Style
Earloop or Tie on
Feature
Safe/Soft/Comfort
Classify
3 Ply Disposable Nonwoven Medical Face Mask with D
Application
Factories, Food Processing, Beauty Salon
Transport Package
50PCS/Box,40boxes/Carton;50PCS/Box,600PCS/Carton
Specification
17.5*9.5cm
Trademark
WELLMIEN or OEM
Origin
Jiangsu
HS Code
6307900090
Production Capacity
6, 000, 000 Pieces / Month

Product Description

Disposable FDA 510k Face Mask

Product Description

Item Value
Size 17.5*9.5 cm
Material 3-ply: SBPP+MB+SBPP
Style Ear-loop
Color Blue, Green, Pink, or as customized
Certification FDA 510K, ISO13485, CE
Structure without face visor
Type Without soft foam
Nose clip double wire
Feature Breathable, soft, Disposable
Function Anti-pollution
Usage Hospital Medical, Daily protection

Specification:

1. Conform to EN14683:2019.

2. Glass fiber-free and latex-free.

3. Breathing Resistance (Delta P)<4.0 

4. Bacterial Filtration Efficiency (BFE%) >99%

5.Particle Filtration Efficiency(PFE%)>99%.

6. Synthetic Blood Penetration Resistance: 120mmHg.

Detailed Photos


Disposable FDA 510k Face Mask
Disposable FDA 510k Face Mask
Disposable FDA 510k Face Mask
Disposable FDA 510k Face Mask
Disposable FDA 510k Face Mask

Product Feature

[Scope of Application]: It covers the user's mouth, nose, and jaw to provide a physical barrier against the direct penetration of pathogens, microorganisms, body fluids, particles, etc.

[Raw Materials, Structure, and Composition of the Product]:
The Surgical Mask consists of a mask body, a nose clip, and a mask band. The mask body is divided into three layers: inner and outer layers are polypropylene (PP) non-woven cloth, and the middle layer is polypropylene (PP) melt-sprayed cloth. The nose clip is made of galvanized iron wire with PE material. The masked band is spandex.
[Usage]:
How to wear the surgical mask:

  1. The dark side of the mask should be worn on the outside, while the light side should be close to the mouth. The nose clip should be put on the nose, and the mask should cover the nose and mouth. Two elastic ear-loops hang on each ear.

  2. Put the fingertips on the nose clip, start from the middle, press onward with the fingers and gradually move to both sides, and shape the nose clip according to the shape of the bridge of the nose;

  3. Adjust the mask belt appropriately according to personal comfort.

How to remove surgical mask:
a)Do not touch the front of the mask (contaminated surface).
b)Remove elastic bands from both ears.
c)The elastic band used to hold the mask only is thrown into the clinical waste container.

Certifications

Disposable FDA 510k Face Mask
Disposable FDA 510k Face Mask

 

Packaging & Shipping

Packing:

Normal Packing QTY
(pc)
Carton Size
(cm)
N.G
(kg/ctn)
W.G
(kg/ctn)

Production Time

(day)
50pcs/box
40boxes/ctn
200,000 52X40X36 7.5 8.5 10
700,000
(1X20GP)
15
1,440,000
(1X40GP)
20
1,720,000
(1X40HQ)
20

Remark:

Production time is based on quantity and the time of order confirmation.


Shipping Port: Shanghai or Wuhan.
Packing Picture:
Disposable FDA 510k Face Mask

FAQ

Q: How to choose a suitable mask when I buy a mask for the first time?
A: Confirm the purpose of buying masks

  1. Daily general protection: Nonwoven face mask(3ply, BFE>95%), KN95 mask, KF94 mask
  2. Protection of anti-epidemic personnel: N99 mask, N95 mask
  3. Hospital daily protection: L2/L3 Surgical Mask, Type IIR Surgical mask
  4. Hospital operating room protection: L3 Surgical Mask, Type IIR Surgical mask, or surgical mask with face shield.
  5. Dust particle protection: N99 mask, N95 mask
  6. Outdoor riding protection: Polyurethane mask

Q: How to choose the mask size?
A: Adult or Children
Q: Can you provide a different color face mask?
A: Yes, blue is most the common, pink, purple, black, etc, or as the client requests.

Q: Are you able to custom our box or mask design?
A: Definitely. Mask can be placed printing or cartoon full printing. Any artwork shared with us will be helpful. Box can be printed according to client design or designed by the Wellmien team as well.

Q: Do you have any certificates that can be allowed to import to European countries?
A: Yes, DOC( Declaration of Conformity), CE, and EN14683 standard SGS report.
For example, Wellmien had exported surgical masks to
Switzerland; France, Greece, the United Kingdom, etc.
Documents meet European laws.

Q: Can you share any Corporate Giants that had worked with you?
A: NHS ( the United Kingdom),Singapore( Guardian),TESCO (the United Kingdom),72HRS(Canada),MCJ( USA),O&M (USA) etc.

Q: If you want to know more information about masks, please contact us.

 

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Supporting protective equipment (simple protective bag)

Disposable FDA 510k Face Mask
Disposable FDA 510k Face Mask
Disposable FDA 510k Face Mask





 

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