FDA Certified Level 1 Face Mask
Color: Blue, White, or as requested
Size: 17.5X9.5cm
Material: SBPP,MB,SBPP
Sales Model: Wholesale
Style: Earloop
FDA Certified Surgical Masks-ASTM Level 1 Disposable 3-Ply Medical Face Masks
| Style | Earloop |
| Size | 17.5*9.5cm |
| Material | 3-Ply: SBPP,MB,SBPP |
| Certification | FDA 510K, ISO13485 |
| Structure | without face visor |
| Type | without soft foam |
| Nose clip | double wire |
| Specification | 1.Conform to FDA510K (No:K101000). 2. Glass fiber-free and latex-free. |
Wellmien Performance for ASTM Level 1 Medical Mask:
Standard Class | Breathing Filtration Efficiency (BFE) | Breathing Resistance (mmH20/cm2) | Splash Resistance | Particulate Filtration Efficiency (PFE) |
FDA 510K ASTM F 2100-Level 1 | >95% | < 5.0 | 80 | >95% |
[Raw Materials, Structure, and Composition of the Product]:
The structure and composition of surgical masks may vary slightly depending on the specific design and intended use. However, most surgical masks typically consist of the following layers:
Outer layer: This layer is usually made from a water-resistant non-woven material that helps to repel fluids and protect against splashes and droplets.
Middle layer: This layer is typically made from a melt-blown fabric that provides excellent filtration properties, capturing small particles and airborne pathogens.
Inner layer: This layer is usually made from a soft, non-woven material that is comfortable to wear against the skin.
Nose wire: This is a thin, bendable wire that is typically inserted into the top edge of the mask to help it conform to the shape of the wearer's nose and reduce the amount of air that can escape through the top of the mask.
Ear loops: These are typically made from elastic bands that are attached to the sides of the mask and go over the wearer's ears to hold the mask in place.



[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.
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 China or customer requirements.
Packing Picture:

Remark: To better ensure the safety of your goods, professional, environmentally friendly, convenient, and efficient packaging services will be provided.
FAQ about Masks:
Q: How to choose a suitable mask when I buy a mask for the first time?
A: Confirm the purpose of buying masks
a. Daily general protection: Nonwoven face mask(3ply, BFE>95%), KN95 mask, KF94 mask
b. Protection of anti-epidemic personnel: N99 mask, N95 mask
c. Hospital daily protection: L2/L3 Surgical Mask, Type IIR Surgical mask
d. Hospital operating room protection: L3 Surgical Mask, Type IIR Surgical mask, or surgical mask with face shield.
e. Dust particle protection: N99 mask, N95 mask
f. 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.
A: E-mail: sales@wellmien.com
WhatsApp:+86-15190084069
WeChat: +86-15190084069