FDA/En14683 Certificated Disposable Medical Use Face Mask with Earloop 3ply Disposable Hospital Use Surgical Face Mask
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Product Highlights
- High Filtration Efficiency: Filter rating >98% for bacteria and particles, ensuring safe protection.
- Certified Quality Standards: Holds FDA 510K, CE MDR, ISO13485, ISO9001, and EN14683 certifications.
- Comfortable Latex-Free Design: Features latex-free elastic earloops and adjustable nose clip for secure fit.
- Customizable Packaging: Supports OEM/ODM services with custom logo, design, and packaging options.
- Breathable & Waterproof: 3-ply polypropylene design offers breathability while preventing droplet penetration.
- Flexible Size Options: Standard size 17.5x9.5cm available, with customization options for specific needs.
- Reliable Manufacturer: 20 years of experience with advanced equipment and strict quality management.
- Fast Delivery Support: Standard delivery within 2-3 weeks, with flexible negotiation for urgent orders.
Product Attributes
- Customization
- Available
- Standard
- EN14683-2019
- Filter Rating
- >98%
- Model NO.
- A-31
- Available Times
- Disposable
- Type
- Medical Surgical Mask
- Layers
- 3 Ply
- Style
- Earloop
- Shape
- Flat
- Sterilization
- Non Sterilization
- Age Group
- Adult
- Color
- Blue
- Item Name
- Disposable Medical Use Face Mask with Earloop
- Art No.
- a-31
- Material
- Polypropylene+Meltblown+Polypropylene
- Certificates
- 510K/ISO13485/ISO9001/En14683/CE Mdr/Ukca
- Sample
- Free Sample
- Application
- Hospital, Pharmacy, Laboratory, etc
- Shipping Ports
- Wuhan, Shanghai, Guangzhou, etc
- Transport Package
- 50PCS/Box, 40boxes/Case
- Specification
- 17.5x9.5cm
- Trademark
- ODM or OEM
- Origin
- Xiantao, Hubei
- Production Capacity
- 50 Forty-Foot Container/Month
Product Images of FDA/En14683 Certificated Disposable Medical Use Face Mask with Earloop 3ply Disposable Hospital Use Surgical Face Mask
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Product Description
Earloop Face Mask: Made by soft non-woven material, and with 3-ply design, non-irritating and good protective. Professional material, strict producing process and expert workers, make face mask more safe and reliable. Excellent filtration for bacterial and particle, you can use it in hospital, laboratory and clinic. And with double elastic, it is latex-free and flexible, can provide good wearing experience for you.
| Product Name | Level-3 Surgical Face Mask |
| Art No. | A-31 |
| Material | Polypropylene+Meltblown+Polypropylene |
| Layer | 3-ply |
| Model | With earloop(latex-free elastic rubber) |
| Size | 17.5x9.5cm, or customized |
| Color | White, green, blue |
| Certificates | CE MDR/ISO13485/ISO9001/EN14683/FDA 510K/UKCA |
| Origin | Xiantao, Hubei, China |
| Brand | AMMEX-WEIDA or OEM |
| Type | Single use, non-sterile |
1. 3-ply design: Polypropylene+Meltblown+Polypropylene, professional material and more safe
2. With latex-free elastic, it is not irriating for skin and no tightness for use
3. Waterproof deisgn and breathable, it is ventilate for use and prevent droplet
4. Excellent filtration for bacterial and particle, provide safe and reliable wearing experience
5. Adjustable nose clip, it is more better for fit your face, and non-stimulating for face
6. Light weight and reasonable thickness, easy to carry on and save storage space
| Packing | 50pcs/box, 40boxes/case, can be adjusted by your requirement |
| MOQ | 50 cases |
| Availability | 50 Forty-Foot Container/Month |
| Ports | Wuhan, Shanghai, Guangzhou, etc |
| Payment | L/C, D/A, D/P, T/T, Western Union, MoneyGram |
| Delivery Time | 2-3 weeks, can be negotiated |
We have obtained ISO9001 and ISO13485 quality management system certification, Class I and II licenses for medical devices, and obtained Sedex international social responsibility certification and CE, FDA, Nelson testing certificates in the United States, etc. At the same time, we have obtained the European standard EN14683 medical mask certificate, and the US FDA 510K Medical mask (level-3) certificate, as well as European standard CAT3 type4/5/6 industrial protective clothing certificate and EN14126 type4B/5B/6B medical protective clothing certificate.

- Hold the mask vertically and place the nose clip bar upper.
- Put the mask cling tightly to the face , ans nose clip bar to the bridge of nose.
- Hang on the elastic to the ears, and adjust it according to the user's face .
- Adjust the nose clip bar according to user's face.
- Make the test whether the mask wears tightly as the following steps: Place your hands on the mask to confirm whether the mask is worn in the correct position. If there is air flow around, please tighten the nose clip bar. If air leaks from the edges, adjust the elastic to make it fit better.
Hubei TDL Group is made of Hubei Orient International Trading Corporation and Ammex-Weida(Hubei) Health and Safety Products Co., Ltd. Our company mainly specialize in healthcare products. We provide a wide range of disposable products for the safety and hygiene industries, as well as hospitals, food service and electronic industries, laboratories and cleanrooms, etc.
With 20 years of regional manufacturering experience, advanced equipment, from selecting the raw materials to the processing with the imported materials, to testing product, a series of strict management system and clean production environment, we can produce any quantities as your needs, duplicate your existing package design, and also create a package design that will uniquely brand your company' product.
We've participated in many exhibitions, gained many valuable experience and developed many clients, like 2014 in Arab, 2016 in Dubai, 2017 in Iran and Thailand, 2018 in Japan, 2019 in Germany and Korea, 2024 in Germany, etc.
Q: 1. How to make an inquiry?
A: Pls tell us the material, size, quantity of product you need, as well as your preferred delivery method. We welcome first time buyers. Simply send us pictures of the articles you need us to provide or tell us of your requirements. Welcome to email or call us, we will try our best to help.
Q: 2. Can we Design the packing with own LOGO?
A: Yes, we can produce all the packing based on your require, including the material of carton , color, design of mark and so on.
Q: 3. How about samples?
A: After confirming the price, we will supply free samples for you to check the quality, and make mass production after you confirm the sample
Q: 4. What certificates do you have?
A: We got the ISO13485, ISO9001, CE MDR certificate, Type 5/6.
Q: 5. What are your main products?
A: Our main products include disposable face mask, isolation gown, coverall, lab coat, surgical gown, disposable cap, apron, shoe cover, disposable gloves etc.
Q: 6.What are the payment terms?
A: We accept T/T(PayPal for small orders, Company account for regular orders), L/C at sight.
For established customers, we can discuss the L/C (extension of credit time) or DP payment, or other payment terms.
Q: 7.What if there is problem with the products after receiving?
A: We take pictures for you before shipping confirmation. If you note any production deficiencies, please send us notice (product pictures by email). We will correct what is not suitable or make other compensation.
About the Supplier
This supplier has been audited by SGS. Verify the report on the official SGS website with ID "QIP-ASR2491035". Items marked "" are certified.
Company Profile
Ammex-Weida (Hubei) Health and Safety Products Co., Ltd and Hubei Orient International Trading Corporation mainly specialize in healthcare products. We provide a wide range of disposable products for the safety and hygiene industries, as well as hospitals, food service and electronic industries, laboratories and cleanrooms, etc.
We've got CE, ISO9001, ISO13485, EN14683, UKCA, FDA 510K and Type 5/6 certificates.
With over eighteen years of region manufacturing experience, advanced equipment, from selecting the raw materials to the processing with the imported materials, to testing products, a series of strict management system and clean production environment, we can produce any quantities as your needs, duplicate your existing package design, and also create a package design that will uniquely brand your company' product. Ammex-Weida (Hubei) Health and Safety Products Co., Ltd specializes in the production of disposable nonwoven & plastic items, such as caps, face mask, lab coats, coveralls, isolation gown, oversleeves, apron, shoe covers, boot covers, etc.
All of us are just to offer you a strong shield of the best quality and price in the fiercely competitive market and to achieve a win-win situation. We believe our future will be more brilliant with your joining.
About Our Factory & Business Background
-
Business Type
- Manufacturer/Factory & Trading Company
- Address
- Room 505, Bldg No. 8, Soho Town, Cbd, Huaihai Road, Jianghan District, Wuhan, Hubei, China
-
Plant Area
- 19673.08 square meters
-
Number of Employees
- 50
-
Terms of Payment
- LC, T/T, D/P, PayPal, Western Union, Small-amount payment
-
International Commercial Terms(Incoterms)
- FOB, CIF, CFR, EXW
- Average Lead Time
-
Peak Season Lead Time: one month
Off Season Lead Time: within 15 workdays -
Nearest Port
- Wuhan Port
-
Minimum Order Quantity
- 100000 Pcs
-
Supply Chain Partners
- 38
Our Production Capability & Technical Expertise
-
Main Products
- Medical Face Mask, Isolation Gown, CPE Gown, Cap, Shoe/Boot Covers, Lab Coat, Scrub Suit, Oversleevs, Apron, Bed Sheet
-
Production Lines
- 5
-
Production Machines
- Face Mask Machine, Stripper Cap Machine, Shoe Cover Machine, Three & Four Thread Sewing Machine, Flat Sewing Machine, Vacuum Packaging Machine, Seal Machine, Electric Scissors, Pure Water System
-
QA/QC inspectors
- 2 people
-
Inspection Type for Finished Products
- 100% inspection(Visual inspection)
-
Inspection Method for Finished Products
- Have instructions and uniformly followed
-
Customization Options
- Customization from Samples
-
ODM Service Available
- Yes
-
OEM Service Available
- Yes
-
R&D Engineers
- 1 people
-
Traceability of Raw Materials
- Yes
-
Own Brand
- Yes
Our Industry Experience & Global Business Record
-
Year of Establishment
- 2003-07-08
-
Export Year
- 21 Years
-
Main Markets
- North America, South America, Europe, Southeast Asia/ Mideast, Africa, East Asia(Japan/ South Korea), Australia
-
Repeat Buyers Choice
- 80%~100%
-
Number of Foreign Trading Staff
- 8
-
Overseas Agent/Branch
- No
-
New Products Launched in Last year
- Yes
Our Certifications, Standards & Industry Recognition
-
Management System Certification
- ISO9001:2015, Others
FAQ
- How to make an inquiry?
- Please provide the material, size, quantity, and preferred delivery method. You can also send pictures or describe your requirements via email or phone.
- Can we design the packing with our own LOGO?
- Yes, we can produce packaging based on your requirements, including carton material, color, and mark design.
- How about samples?
- After confirming the price, we supply free samples for quality check. Mass production begins after you confirm the sample.
- What certificates do you have?
- We hold ISO13485, ISO9001, CE MDR, Type 5/6, FDA 510K, and EN14683 certificates.
- What are your main products?
- Our main products include disposable face masks, isolation gowns, coveralls, lab coats, surgical gowns, caps, aprons, shoe covers, and gloves.
- What are the payment terms?
- We accept T/T (PayPal for small orders), L/C at sight, and can discuss L/C extension or DP for established customers.
- What if there is a problem with the products after receiving?
- Please send product pictures via email if you note any deficiencies. We will correct issues or provide compensation.
Send your message to this supplier
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