FDA 510K 3-Ply Medical Face Mask Disposable Surgical Protective Mask
|
Still deciding? Get samples of $ !
Request Sample
|
| Customization: | Available |
|---|---|
| Type: | Surgical Supplies Materials |
| Material: | Non-Woven Fabric, Nonwoven Fabric |
Suppliers with verified business licenses
Audited Supplier Audited by an independent third-party inspection agency
Find Similar Products
Basic Info.
- Model NO.
- WELLMIEN-FM008
- Ethylene Oxide Sterilization
- Without Ethylene Oxide Sterilization
- Quality Guarantee Period
- Two Years
- Group
- Adult or Children
- Logo Printing
- With Logo Printing
- 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
- WELLMIEN OR OEM
- Origin
- Jiangsu
- HS Code
- 6307900090
- Production Capacity
- 6, 000, 000 Pieces / Month
Product Description
Our FDA 510k 3-Ply Medical Face Mask provides reliable protection for medical professionals and patients. Constructed with three layers of high-quality nonwoven fabric, including a melt-blown filter layer, this mask effectively blocks bacteria, droplets, and other airborne particles.
The soft elastic earloops and adjustable nose clip ensure a secure and comfortable fit for long-term wear. Lightweight and hypoallergenic, these masks are suitable for use in hospitals, clinics, laboratories, dental offices, and public health protection. OEM and bulk customization are available for color, packaging, and branding.
| 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 |
Key Benefits:
-
FDA 510k Certified: Meets medical safety standards.
-
3-Ply Protection: Outer hydrophobic layer, melt-blown filter, soft inner layer.
-
Comfortable Earloops: Reduce ear fatigue during extended use.
-
Adjustable Nose Clip: Provides secure fit and reduces fogging.
-
Hypoallergenic & Breathable: Comfortable for sensitive skin.
Applications:
Hospitals, clinics, laboratories, dental offices, public health protection, personal use.
[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:
-
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.
-
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;
-
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.
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:
Q: How to choose a suitable mask when I buy a mask for the first time?
A: Confirm the purpose of buying masks
- Daily general protection: Nonwoven face mask(3ply, BFE>95%), KN95 mask, KF94 mask
- Protection of anti-epidemic personnel: N99 mask, N95 mask
- Hospital daily protection: L2/L3 Surgical Mask, Type IIR Surgical mask
- Hospital operating room protection: L3 Surgical Mask, Type IIR Surgical mask, or surgical mask with face shield.
- Dust particle protection: N99 mask, N95 mask
- 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.
Supporting protective equipment (simple protective bag)
){kind=link}
Send your message to this supplier
People who viewed this also viewed
Product Groups
Find Similar Products By Category
- Supplier Homepage
- Products
- Face Masks
- Daily Protective Mask
- FDA 510K 3-Ply Medical Face Mask Disposable Surgical Protective Mask