face mask 4-ply bike face maks with fda
The masks we supply are specifically designed to be used in high risk environments.
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:
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.
White, blue, green, yellow or etc.
17.5cmx9.5cm (adult), 14.5x9.5cm (children) or as your required
Earloop or tie on
Usually 3 ply
18/20/25 or as your request
The nose bar is metal band, which can be bended easily and adapt to the contour of the nose
Triple-layers; Latex free; low breathing resistance; it can prevent blood, body fluids and splash objects
Used in clinic, hospital, pharmacy, restaurant, food processing, beauty salon, electronics industry etc.