High Quality Ear-Loop Cleaning Medical Face Masks
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Product Highlights
- FDA 510K & EN14683 Certified: Passed Nelson Labs testing with FDA 510(K) No. K101000 and EN14683:2019 compliance.
- Customizable Colors: Available in white, blue, green, yellow, pink, or as requested by the customer.
- Flexible Nose Clip Options: Choose from single/double nose wire, plastic, or aluminum nose clips for better fit.
- OEM and ODM Services: Full customization, minor customization, and customization from samples or designs available.
- Fast Production Lead Time: Standard production time is 10 days, with peak and off-peak seasons both within 15 workdays.
- Diverse Size Options: Available in Adult (17.5x9.5cm) and Child (14.5x9.5cm) sizes, plus 15x9cm option.
- Two-Year Quality Guarantee: Comprehensive quality guarantee period covering two years for all products.
Product Attributes
- Customization
- Available
- Type
- Face Mask/Apron/Gloves
- Material
- Non-woven Fabric
- Model NO.
- WELLMIEN-FM0024
- 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 High Quality Ear-Loop Cleaning Medical Face Masks
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Product Description
| Product Description | |
| Name | disposable FDA 510K/EN14683 surgical dental medical face masks |
Structure |
3-ply: SBPP+MB+SBPP with face visor or without with soft foam or without |
Style |
earloop |
| Nose clip | single nose wire double nose wire plastic nose clip aluminum nose clip |
Size |
Adult: 17.5*9.5cm Child: 14.5*9.5cm |
Color |
white/blue/green/yellow/as requested |
Standard Class |
Bacteria Filtration Efficiency (BFE) |
Breathing Resistance (mmH2O/cm2) |
Splash Resistance (mmHg) |
Particluate Filtration Efficiency (PFE) |
|
FDA 510 (K) |
>99% |
<5.0<> |
120/160 |
>99% |
|
EN14683 |
Type I |
>98% |
<3.0<><5.0<> |
N/A |
N/A |
Type IR |
>98% |
<5.0<><3.0<><5.0<> |
120 |
N/A |
|
Type II |
>99% |
<3.0<><5.0<><3.0<><5.0<> |
N/A |
>98% |
|
Type IIR |
>99% |
<5.0<><3.0<><5.0<><3.0<><5.0<> |
120/160 |
>98% |
|
Specification:
1.Size: 15 x 9cm, 17.5 x 9cm, 17.5 x 9.5cm.
2. Distinguish with appearance: Sewing edge; Folded edge; Auto edge.
3.Colors: White/pink/green/blue/yellow.
4.Conform to EN14683: 2019 and FDA510K(No.:K101000)
Passed the testing by Nelson Labs of the USA.
5. Fiberglass-free.
6. Adaptable nose bar.
7. High filter efficiency.
[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 product 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.
[Product Contraindications]: None.
[Usage]:
How to wear the 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.
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:
If you like, you can choose other styles of masks:
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
- What certifications does the mask have?
- The masks are certified under FDA 510(K) (No. K101000) and EN14683:2019, tested by Nelson Labs USA.
- Can I customize the mask colors?
- Yes, we offer customization for colors including white, blue, green, yellow, pink, or specific requests.
- What is the minimum order quantity?
- The minimum order quantity is 10,000 pieces.
- How long does production take?
- Production time is typically 10 days, and within 15 workdays during peak or off-peak seasons.
- Is the mask sterile?
- No, these masks are non-sterile and do not undergo ethylene oxide sterilization.
- What materials are used in the mask?
- The mask consists of three layers of polypropylene non-woven cloth and a galvanized iron wire nose clip with PE material.
- Do you offer OEM and ODM services?
- Yes, we provide full customization, minor customization, and customization from samples or designs.
- What are the available sizes?
- We offer Adult sizes (17.5x9.5cm), Child sizes (14.5x9.5cm), and a 15x9cm option.
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