ASTM Level 3 Disposable Medical Surgical Face Mask Nonwoven Earloop Mask
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Product Highlights
- ASTM Level 3 Certification: FDA 510K certified with BFE/PFE >99% and 160mmHg blood penetration resistance.
- Customizable Colors: Available in Blue, Green, White, Yellow, Pink, and other colors as per client request.
- OEM/ODM Service: Accepts custom mask designs, printing, and packaging according to client artwork.
- Latex-Free Material: Free of glass fibers and latex, ensuring safety for sensitive users.
- European Market Ready: Holds CE, ISO13485, and EN14683 standards for EU import compliance.
- Flexible MOQ: Minimum order quantity starts at 10,000 pieces for wholesale orders.
- Fast Production Time: Lead time ranges from 10 to 20 days depending on order quantity.
Product Attributes
- Customization
- Available
- Standard
- ASTMF2100
- Filter Rating
- 95%-99%
- Model NO.
- WELLMIEN-SM001
- Available Times
- Disposable
- Type
- Medical Surgical Mask
- Layers
- 3 Ply
- Style
- Earloop or Tie on
- Shape
- Flat
- Sterilization
- Non Sterilization
- Age Group
- Adult
- Color
- Blue, Green, White, Yellow
- Outer Layer
- Spunbonded Polypropylene 33GSM
- Filter Layer
- Melt-Blown Filter Paper 33GSM
- Inner Layer
- Spunbonded Polypropylene 25GSM
- Ear Loop
- Elastic Spandex, Latex Free
- Nose Strip
- Polyethylene Coated Double Galvanized Wire
- Approximate Weight of Product
- 3.3 Grams / 0.11 Oz
- Bacterial Filtration Efficient(Bfe)
- 99%
- Particulates Filtration Efficient(Pfe)
- 99%
- Breathing Resistance
- 60 Mmh20/Cm2
- Synthetic Blood Penetration Resistance
- 160mmhg
- Feature
- Soft, Breathable
- Sample
- Freely
- OEM
- Accept
- Certificate
- ISO13485:2016
- Application
- Mainly Used in Hospital
- Transport Package
- 50PCS/Box, 40boxes/CTN: 50PCS/Box, 12boxes/CTN
- Specification
- 17.5*9.5cm
- Trademark
- WELLMIEN OR OEM
- Origin
- Jiangsu, China(Mainland)
- HS Code
- 6307900090
- Production Capacity
- 60, 000, 000 pcs / month
Product Images of ASTM Level 3 Disposable Medical Surgical Face Mask Nonwoven Earloop Mask
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Product Description
This Level 3 face mask is designed for healthcare buyers looking for a disposable medical and surgical mask for routine clinical use. It features a lightweight nonwoven construction with elastic earloops for convenient wearing.
For buyers who require an ASTM Level 3 face mask, the product can be supplied according to the applicable specification and documentation.
Level 3 Protection for Healthcare Applications
The disposable surgical mask is designed for use in professional healthcare environments where a higher-level surgical mask is required.
The multi-layer construction combines nonwoven materials with a filtration layer to provide a practical combination of filtration, breathability and comfort.
For buyers sourcing an ASTM F2100 Level 3 surgical mask, applicable test reports and product documentation should be confirmed according to the selected specification.
| 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 |
Nonwoven Multi-Layer Construction
The nonwoven face mask uses a layered construction designed for routine medical applications. The pleated structure allows the mask to expand over the nose and mouth, while the elastic earloops make it easy to put on and remove.
The lightweight construction is suitable for extended periods of routine clinical work.
Hospital & Dental Applications
This medical face mask is suitable for a range of healthcare environments, including:
- Hospitals
- Dental clinics
- Medical clinics
- Laboratories
- Nursing and care facilities
- Healthcare institutions
- Medical examination areas
For buyers looking for a surgical face mask for dental use, the product can be considered for routine dental and clinical applications according to the applicable requirements.
Bulk Supply for B2B Buyers
The disposable face mask is suitable for hospitals, healthcare distributors, importers and institutional procurement projects.
Wellmien supports international B2B sourcing with bulk supply and selected OEM options. Packaging, logo, color and other agreed specifications can be discussed according to order quantity.
For buyers looking for a medical face mask supplier, product specifications, documentation and packaging options can be reviewed before order confirmation.
[Scope of Application]:
Designed to cover the user's mouth, nose, and jaw, providing a physical barrier against the direct penetration of pathogens, microorganisms, body fluids, and particles.
[Raw Materials, Structure, and Composition]:
The surgical mask consists of:
- Mask Body: Composed of three layers:
- Inner and outer layers: Polypropylene (PP) non-woven fabric.
- Middle layer: Polypropylene (PP) melt-blown fabric.
- Nose Clip: Made of galvanized iron wire coated with PE material.
- Mask Band: Made of spandex.
[Usage]:
How to Wear the Surgical Mask:
- Ensure the dark side of the mask faces outward, and the light side is against the mouth.
- Position the nose clip over the bridge of the nose, ensuring the mask covers both the nose and mouth.
- Place the elastic ear loops around each ear.
- Use your fingertips to shape the nose clip by pressing from the center outward to conform to the bridge of the nose.
- Adjust the mask for a comfortable fit.
How to Remove the Surgical Mask:
- Avoid touching the front surface of the mask (contaminated area).
- Carefully remove the elastic bands from both ears.
- Dispose of the mask by placing it in a clinical waste container, ensuring the elastic bands are included.
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. For daily general protection, choose Nonwoven face mask(3ply, BFE>95%), KN95, or KF94. For anti-epidemic personnel, use N99 or N95. For hospital daily protection, select L2/L3 Surgical Mask or Type IIR. For operating rooms, use L3 Surgical Mask, Type IIR, or masks with face shields. For dust protection, choose N99 or N95. For outdoor riding, use Polyurethane masks.
- How to choose the mask size?
- Available sizes are for Adult or Children.
- Can you provide a different color face mask?
- Yes, blue is most the common, 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 for orders?
- Production time is based on quantity and the time of order confirmation. It is 10 days for 200,000 pcs, 15 days for 700,000 pcs (1X20GP), and 20 days for 1,440,000 pcs (1X40GP) or 1,720,000 pcs (1X40HQ).
- What are the main features of this surgical mask?
- The mask is breathable, soft, and disposable. It consists of 3-ply SBPP+MB+SBPP material, has a double wire nose clip, and ear-loop style. It is free of glass fibers and latex.
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