FDA 510k 3 Ply Medical Face Mask

• Type: Surgical Supplies Materials
• Material: Non-Woven Fabric, Nonwoven Fabric
• Ethylene Oxide Sterilization: Without Ethylene Oxide Sterilization
• Quality Guarantee Period: Two Years
• Group: Adult or Children
• Logo Printing: With Logo Printing
• Model NO.: WM-FM131
• Standard: EN14683-2019
• Filter Rating: Bfe99% or Bfe95%
• Place of Origin: Jiangsu, China
• Brand Name: Wm
• Color: Blue, White, Green
• Style: Earloop or Tie on
• Size: 17.5*9.5cm
• Feature: Filter Pollen, Dust and Bacteria
• Classify: FDA510K 3 Ply Medical Face Mask
• Application: Used in Hospital or by Normal Citizen
• Transport Package: 50PCS/Box, 40boxes/CTN, 50box/Bag, 600PCS/CTN
• Specification: Adult: 17.5*9.5cm; Child: 14.5*9.5cm
• Trademark: WM
• Origin: Jiangsu
• HS Code: 6307900090
• Production Capacity: 6, 000, 000 Pieces / Month

Product Description

FDA 3 ply Medical Face Mask
Specification:

1.Size: 14.5 x 9cm, 17.5 x 9cm, 17.5 x 9.5cm, 21 x 9cm.

2.Distinguish with appearance: Sewing edge; Folded edge; Auto edge.

3.Colors: White/pink/green/blue/yellow.

4.Conform to EN14683: 2005 and FDA510K(No.: K101000).

5.Passed the testing by Nelson Labs of the USA.

6.Bacterial filtration efficiency (BFE%) > 98%.

7.Differential pressure (Delta P) < 29.4.

8.Fiberglass free.

9.Adaptable nose bar.

10.High filter efficiency.

11.Latex free.

12.Tie on or earloop.

About Us:
Wellmien is a company specializing in the manufacture and trade of disposable medical products and personal protection equipments (PPT).Our company has implemented a strict quality management (QMS) and has passed ISO13485 certification.Our main products have passed CE Certification of European Union(EU) and FDA registration of USA.Wellmien surgical masks meet EN14683 standards of EU,and also have acquired FDA 510K approval of USA.With Superior products and services ,our company had been winning the trust and support of new and old customers.
Display Pics of Our Company and Factory:

Our Qualifications:
Our Advantage and Service:
1.We have strict QC quality control system. Examine every one of the Face masks carefully.
2.One-stop service :excellent disposable medical products ,personal protection equipments.
3.Welcome any OEM requirements
4.Qualified products,100% new brand material ,safe and sanitary.
5.Offered free samples .
6.Professional shipping service if necessary.
7.Full series after sales service system.

Sample Policy:
1.Sample according to your design drawing. Sampling time:3-5days .
2. Design your own sample, then remake it .
3. Existing Samples Sampling time:1day
4. Make mass production after your confirm the sample.

Q C:
1.We will not start to make the products until you confirm the sample.
2. The packing will be water-proof, damp-proof and sealed.
 

Color	White, blue, green, yellow or etc.
Size	17.5cmx9.5cm (adult), 14.5x9.5cm (children) or as your required
Style	Earloop or tie on
BFE	>99%
Standard	CE,ISO13485
Gram	18/20/25 or as your request
Nose bar	Nose bar can be adaptable,comfortable,without glass fibres,latex free.
Feature	Triple-layers; Latex free; low breathing resistance; it can prevent blood, body fluids and splash objects.
Standard	CE,ISO13485
Application	Dust-free workshop,hospital, laboratory, food industry, electronic manufactures and so on.