Disposable FDA 510k/En14683 Breathing Bacteria Medical Face Masks
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Product Highlights
- FDA 510k & CE Certified: Conforms to FDA 510K (K101000) and holds CE, ISO 13485 certifications for medical use.
- High Filtration Efficiency: Particle and Bacteria Filtration Efficiency (PFE/BFE) exceeds 99% for effective protection.
- Customizable Design: Supports full customization including size, color, logo printing, and nose clip style.
- Two-Year Quality Guarantee: Comes with a comprehensive two-year quality guarantee period for all products.
- Comfortable & Breathable: Made of non-woven fabric with adjustable nose piece and earloops for a secure fit.
- OEM/ODM Services: Offers flexible customization options from samples and designs with professional service.
- Fast Sample Delivery: Existing samples ready in 1 day; custom design samples delivered within 3-5 days.
- Safe Material Composition: Glass fiber free and latex free, ensuring safety for sensitive skin and users.
Product Attributes
- Customization
- Available
- Type
- Face Mask/Apron/Gloves
- Material
- Non-woven Fabric
- Model NO.
- WELLMIEN-FM0043
- Ethylene Oxide Sterilization
- Without Ethylene Oxide Sterilization
- Quality Guarantee Period
- Two Years
- Group
- Adult & Child
- Logo Printing
- With Logo Printing
- Size
- Adult: 17.5*9.5cm / Child: 14.5*9.5cm
- Layer
- 3ply
- Style
- Earloop
- Color
- White/Blue/Green/Yellow etc.
- Nose Clip
- Single Nose Wire/Double Nose Wire/Plastic Nose Cli
- Certificate
- Ce, ISO 13485, FDA 510(K)
- Sterile
- Nonsterile
- 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 Disposable FDA 510k/En14683 Breathing Bacteria Medical Face Masks
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Disposable FDA 510k/En14683 Breathing Bacteria Medical Face Masks -
Disposable FDA 510k/En14683 Breathing Bacteria Medical Face Masks -
Disposable FDA 510k/En14683 Breathing Bacteria Medical Face Masks -
Disposable FDA 510k/En14683 Breathing Bacteria Medical Face Masks -
Disposable FDA 510k/En14683 Breathing Bacteria Medical Face Masks -
Disposable FDA 510k/En14683 Breathing Bacteria Medical Face Masks -
Disposable FDA 510k/En14683 Breathing Bacteria Medical Face Masks
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Product Description
Characteristics:
A. Conform to FDA 510K of the USA (NO: K101000)
B. Fluid splash resistance
C. Particle filtration efficiency (PFE) > 99%
D. Bacteria filtration efficiency (BFE) > 99%
E. Differential pressure (Delta-P) > 4.5 mm H2O/cm2
F. Class I none flammable
G. Biocompatile
H. Non- irritating
I. Glass fiber free and latex free
J. Adjustable nose piece for easy use
K. Non-sterile
L. For single use
Sample Policy:
Factory direct sale new breathing mask Protective masks general face mask
1. Sample according to your design drawing. Sampling time: 3-5days.
2. Design your own sample, then remake it.
3. Existing Samples Sampling time: 1day
4. Make mass production after your confirm the sample.
Quality Control:
1. We will not start to make the products until you confirm the sample.
2. The packing will be water-proof, damp-proof and sealed.
Our Advantage:
1. CE, ISO13485 certification.
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.
| Standard Class | Bacterial Filtration Efficiency(BFE) | Breathing Resistance(mmH20/cm2) | Splash Resistance(mmHg) |
| Type I | >98% | <3.0 | N/A |
| Type IR | >98% | <5.0 | 120 |
| Type II | >99% | <3.0 | N/A |
| Type IIR | >99% | <5.0 | 120 |
Description :
Keep Safe: These Face masks are class 1 medical devices, and can be used for healthcare use, but should not be used in surgical or high risk situations, or where there is a high risk of contact with liquids or infectious materials.
Comfort & Breathable: Made with non-woven fabric for effective airway protection from small particles and droplets. Soft, non-irritating, comfortable and breathable. Adjustable earloop and nose clip fits for most of faces. Perfect for men, women, adults.
Care: Protect ourself and our loved ones with this disposable face masks in various environments such as home, office, school, gardening, construction, and also the work places as other public areas to help protect from allergens, dust and germs.
One Time Use: All these disposable masks are not recommend washable or reusable but for one time use and recommend to replace by each 4 hours.
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.
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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
- What certifications does this mask have?
- The masks are FDA 510k certified (No: K101000), CE certified, and ISO 13485 certified.
- What is the filtration efficiency?
- The mask offers Particle Filtration Efficiency (PFE) and Bacteria Filtration Efficiency (BFE) both greater than 99%.
- Can I customize the mask design?
- Yes, we offer full customization including size, color, logo printing, and nose clip style based on your design.
- Is the mask reusable?
- No, these are disposable masks intended for single use only. They should be replaced every 4 hours.
- What is the minimum order quantity?
- The minimum order quantity is 10,000 pieces.
- How long does it take to produce samples?
- Existing samples take 1 day, while custom design samples take 3-5 days.
- What is the warranty period?
- We provide a two-year quality guarantee period for our products.
- What are the available payment terms?
- We accept LC, T/T, PayPal, D/P, Western Union, and small-amount payments.
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