En 14863 Disposable Nonwoven Medical Surgical Face Mask
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Product Highlights
- FDA 510K Certification: Conforms to FDA 510K (No:K101000) for medical use.
- High Filtration Efficiency: BFE >99% and PFE >99% with 3-ply SBPP+MB+SBPP structure.
- Customizable Colors: Available in Blue, Green, Pink, Purple, Black, or as client request.
- Custom Logo Printing: Supports printing, cartoon full printing, or client artwork on masks.
- Breathable & Soft: Delta P <6.0 mmh2o ensures comfortable breathing during use.
- Latex and Glass Free: Safe for sensitive users with no glass fiber or latex content.
- OEM/ODM Services: Full customization available from samples, designs, or minor adjustments.
- CE and ISO Certified: Meets CE, ISO13485, and EN14683 standards for European import.
Product Attributes
- Customization
- Available
- Standard
- ASTMF2100
- Filter Rating
- Normal
- Model NO.
- WELLMIEN-FM012
- Available Times
- Disposable
- Type
- Face Mask/Apron/Gloves
- Layers
- 3 Ply
- Style
- Earloop
- Shape
- Flat
- Sterilization
- as Customized
- Age Group
- Adult
- Color
- White/Blue/Green/Yellow etc.
- Size
- Adult: 17.5*9.5cm / Child: 14.5*9.5cm
- Layer
- 3ply
- Nose Clip
- Single Nose Wire/Double Nose Wire/Plastic Nose Cli
- Certificate
- Ce, ISO 13485, FDA 510(K)
- Sterile
- Nonsterile
- Material
- Non-woven Fabric
- Certification
- CE, FDA, ISO13485
- Ethylene Oxide Sterilization
- Without Ethylene Oxide Sterilization
- Quality Guarantee Period
- Two Years
- Logo Printing
- With Logo Printing
- Group
- Adult & Child
- Transport Package
- 50PCS/Box, 40boxs/CTN
- Specification
- Adult: 17.5*9.5cm; Child: 14.5*9.5CM
- Trademark
- WELLMIEN OR OEM
- Origin
- Jingsu, China(Mainland)
- HS Code
- 63079000
- Production Capacity
- 9000000PCS/Month
Product Images of En 14863 Disposable Nonwoven Medical Surgical Face Mask
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Product Description
For hospitals, clinics and healthcare distributors, a medical surgical mask needs to be practical for routine use, easy to handle and supported by the documentation required for the target market.
This disposable surgical mask is made from nonwoven material and is designed for routine medical and healthcare applications. The lightweight construction and elastic earloop design make it convenient for daily professional use.
| 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 |
Disposable Nonwoven Surgical Mask
The nonwoven surgical mask uses lightweight nonwoven material and is designed for single-use applications.
Its simple construction makes it suitable for regular procurement by hospitals, clinics, healthcare facilities and distributors that need a reliable supply of disposable medical masks.
The exact material structure and performance should be confirmed according to the selected product specification.
Practical Design for Medical Use
The surgical face mask features an elastic earloop design for convenient wearing and removal during routine work.
The mask is intended for professional environments where disposable face masks are used according to established workplace or healthcare procedures.
For buyers sourcing a disposable medical mask, available specifications such as size, color, packaging and design can be confirmed before quotation.
FDA 510(k) Documentation
Applicable product specifications can be supplied with relevant FDA 510(k) documentation for buyer review.
If you are looking for an FDA 510(k) surgical mask supplier, we recommend confirming the exact product model, applicable documentation and destination-market requirements before placing an order.
This is especially important for distributors and institutional buyers supplying regulated healthcare markets.
Custom Printed Options
For buyers looking for a custom printed surgical face mask, available options may include colors, printed designs, packaging and private-label requirements.
Custom requirements are generally more suitable for bulk orders. Buyers can provide their artwork, packaging requirements and estimated quantity so the available options can be confirmed.




[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)
About the Supplier
This supplier has been audited by BV. Verify the report on the official BV website with ID "MIC-ASR2541319". Items marked "" are certified.
Company Profile
Wellmien - Leading Provider of Disposable Medical Supplies & PPE<br/><br/>Founded in 2006, Wellmien is a trusted manufacturer and supplier specializing in disposable medical supplies and Personal Protection Equipment (PPE). With over 300 employees, including 8 dedicated R&D professionals, we are committed to delivering high-quality, innovative products to meet the evolving needs of the healthcare and industrial sectors. Our headquarters are based in Suzhou, China, and our state-of-the-art manufacturing facility spans 8, 000 square meters, featuring a 1, 500 square meter clean room. <br/><br/>Our Product Range: Wellmien offers a comprehensive range of disposable medical products and PPE designed for healthcare, food processing, and industrial applications. Our main products include: <br/><br/>Disposable PPE: <br/><br/>These products are widely used in hospitals, healthcare facilities, food processing, and other industries across Europe, North America, South America, Africa, and Southeast Asia, with annual sales revenue exceeding $10 million USD. We also offer customized OEM services tailored to customer specifications, ensuring product solutions meet the unique needs of our clients. <br/><br/>Commitment to Quality and Compliance: At Wellmien, we adhere to a stringent Quality Management System (QMS) and are ISO 13485: 2003 certified, ensuring the highest standards in manufacturing and product safety. Our products also meet international certifications, including: <br/><br/>CE Certification for the European Union<br/><br/>FDA Medical Device Listing<br/><br/>FDA 510(K) for Surgical Masks<br/><br/>EN14683 Standard for Wellmien Surgical Masks<br/><br/>These certifications reflect our commitment to producing reliable, safe, and compliant products, trusted by customers worldwide. <br/><br/>Our Vision: We are driven by our shared goal of "New Products, Better Quality, and Better Services", striving to continuously enhance our product offerings and support our clients' success. We aim to build long-term partnerships and broaden our reach by expanding our product lines and service capabilities, all while prioritizing human health and safety. <br/><br/>Your Health is Our Eternal Pursuit. At Wellmien, we believe that health is the foundation of a thriving world, and we remain committed to improving health outcomes globally through superior products, innovation, and customer service.
About Our Factory & Business Background
- Address
- 1-3603, Global 188, No. 88 Suhui Road, Suzhou Industrial Park, 215021, Suzhou, Jiangsu, China
-
Number of Employees
- 6
-
Registered Capital
- 5,000,000 RMB
-
Terms of Payment
- LC, T/T, PayPal, D/P, Western Union, Small-amount payment
-
International Commercial Terms(Incoterms)
- FOB, CIF, EXW, CFR
-
Average Lead Time
-
Peak Season Lead Time: within 15 workdays
Off Season Lead Time: within 15 workdays - Nearest Port
- Shanghai, Ningbo, Shenzhen
-
Minimum Order Quantity
- 10000 PCS
-
Supply Chain Partners
- 12
Our Production Capability & Technical Expertise
- Main Products
- Underpads, Surgical Pack, Wound Care, Emergency Blanket, Face Masks, Surgical Masks, Shoe Cover, First Aid Product, Emergency Transfer Sheet, Body Bag
-
QA/QC inspectors
- 1 people
-
Inspection Type for Finished Products
- Random inspection(Visual inspection & Function inspection)
-
Inspection Method for Finished Products
- Have instructions and uniformly followed
-
Customization Options
- Customization from Samples, Customization from Designs, Full Customization, Minor Customization, Flexible customization
-
ODM Service Available
- Yes
-
OEM Service Available
- Yes
-
R&D Engineers
- 1 people
-
Traceability of Raw Materials
- Yes
Our Industry Experience & Global Business Record
- Export Year
- 2006-05-15
- Main Markets
- North America, South America, Eastern Europe, Southeast Asia, Africa, Oceania, Mid East, Eastern Asia, Western Europe
-
Repeat Buyers Choice
- 80%~100%
-
Number of Foreign Trading Staff
- 2
-
Overseas Agent/Branch
- No
-
New Products Launched in Last year
- Yes
Our Certifications, Standards & Industry Recognition
-
Management System Certification
- Others
FAQ
- How to choose a suitable mask when I buy a mask for the first time?
- Confirm the purpose of buying masks: Daily general protection (Nonwoven 3ply, KN95, KF94), Anti-epidemic personnel (N99, N95), Hospital daily protection (L2/L3, Type IIR), Operating room (L3, Type IIR, or with face shield), Dust particle protection (N99, N95), Outdoor riding (Polyurethane mask).
- How to choose the mask size?
- We offer sizes for both Adult and Children.
- Can you provide a different color face mask?
- Yes, blue is most common, but we also offer pink, purple, black, etc., or as the client requests.
- Are you able to custom our box or mask design?
- 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.
- Do you have any certificates that can be allowed to import to European countries?
- 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.
- Can you share any Corporate Giants that had worked with you?
- NHS (the United Kingdom), Singapore (Guardian), TESCO (the United Kingdom), 72HRS (Canada), MCJ (USA), O&M (USA) etc.
- What is the production time?
- Production time is based on quantity and the time of order confirmation. For 50pcs/box, it takes 10 days. For 700,000 pcs (1x20GP), it takes 15 days. For 1,440,000 pcs (1x40GP) or 1,720,000 pcs (1x40HQ), it takes 20 days.
- What is the minimum order quantity?
- The minimum order quantity is 10,000 PCS.
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