Surgical Mask with FDA 510k

• Customization: Available
• Standard: EN14683-2019
• Filter Rating: Normal
• Model NO.: FM-16327-6
• Available Times: Disposable
• Type: Face Mask/Apron/Gloves
• Layers: 3 Ply
• Style: Earloop
• Shape: Flat
• Sterilization: Non Sterilization
• Age Group: Adult
• Color: Blue, Green, White, Pink
• Place of Origin: Jiangsu, China
• Brand Name: Wm
• Composition: Fiberglass Free and Latex Free
• Size: 17.5*9.5cm;14.5*9.5cm
• Classify: Surgical Mask with FDA 510k
• Application: Hospital, Clinic, House, Food Processing Place
• Certification: CE, FDA
• Ethylene Oxide Sterilization: Without Ethylene Oxide Sterilization
• Logo Printing: With Logo Printing
• Quality Guarantee Period: Five Years
• Group: Adult or Children
• Material: Non-Woven Fabric, Nonwoven Fabric
• Transport Package: 50PCS/Box, 40boxes/CTN, 50PCS/Bag, 40bags/CTN
• Specification: CE/ISO13485
• Trademark: WM
• Origin: Jiangsu, China(Mainland)
• HS Code: 6307900090
• Production Capacity: 10, 000, 000 PCS / Month

Product Description

Surgical Mask with FDA 510k

The masks we supply are specifically designed to be used in high risk environments.

Specification:

1. Surgical/Medical face masks with CE, ISO13485.

2. Material: Non woven.

3. Size: 17.5x9.5cm.

4. Layer: 3ply.

5. Style: Tie-on.or earloop.

6. Application: Used for hospital, clinic, house, food processing place and other working/living and studing place where has high request on environment.

7. Conform to EN14683: 2005 TYPE IIR and FDA510K(No.: K101000).

8. Resistance to penetration by synthetic blood-120mmHg.

9. Packing: 50pcs/box, 40boxes/ctn; 50pcs/bag, 40bags/ctn.

10. Sterile: Sterilized by ethylene oxide.

11. Distinguished with appearance: Sewing edge; Folded edge; Auto edge.

12. Bacterial filtration efficiency (BFE%) >99%.

13. Adaptable nose bar, fiberglass free, latex free.

14. MOQ: 50, 000PCS.

15. Payment terms: T/T, L/C.

16. Delivery time: 15days.

Item Detail Information:

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.

Our Advantage and Service:

1. FDA510K, EN14683 type IIR, CE, ISO13485.

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.
 

Material	PP Non-woven
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
Layer	Usually 3 ply
Standard	CE,ISO13485
Gram	18/20/25 or as your request
Nose bar	The nose bar is metal band, which can be bended easily and adapt to the contour of the nose
Feature	Triple-layers; Latex free; low breathing resistance; it can prevent blood, body fluids and splash objects
Standard	CE,ISO13485
Application	Used in clinic, hospital, pharmacy, restaurant, food processing, beauty salon, electronics industry etc.