Disposable FDA 510k Decorative Medical Face Masks

• Type: Face Mask/Apron/Gloves
• Material: Non-woven Fabric
• Ethylene Oxide Sterilization: Without Ethylene Oxide Sterilization
• Quality Guarantee Period: Two Years
• Group: Adult & Child
• Logo Printing: With Logo Printing
• Model NO.: WELLMIEN-FM0013
• Size: Adult: 17.5*9.5cm / Child: 14.5*9.5cm
• Layer: 3ply
• Style: Earloop
• Color: White/Blue/Green/Yellow etc.
• Nose Clip: Single Nose Wire/Double Nose Wire/Plastic Nose Cli
• Certificate: Ce, ISO 13485, FDA 510(K)
• Sterile: Nonsterile
• Transport Package: 50PCS/Box, 40boxs/CTN
• Specification: Adult: 17.5*9.5cm; Child: 14.5*9.5CM
• Trademark: WELLMIEN or OEM
• Origin: Jingsu, China(Mainland)
• HS Code: 63079000
• Production Capacity: 9000000PCS/Month

Product Description

Disposable FDA 510k Decorative Medical Face Masks

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 FDA 510K (No:K101000).

2. Glass fiber-free and latex-free.

3. Breathing Resistance (Delta P)<6.0 mmh2o="">

<6.0 mmh2o="">

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

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

6. Synthetic Blood Penetration Resistance: 160mmHg.

Detailed Photos

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

 

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:

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.
 

One-stop shopping

Supporting protective equipment (simple protective bag)