High Quality 3-Ply FDA 510 K Medical Surgical Face Mask| Product Description |
| Name |
non woven high quality 3-ply hot sale FDA 510 k medical surgical face mask |
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 |
N/A |
N/A |
Type IR |
>98% |
<5.0 |
120 |
N/A |
Type II |
>99% |
<3.0 |
N/A |
>98% |
Type IIR |
>99% |
<5.0 |
120/160 |
>98% |
Packing: 50pcs/box, 40boxed/ctn
Delivery time: 15-30days after receipt of deposit payment
Shipping Port: Shanghai
Our Services
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.
Company Profile
Founded in 2006
Specialized in disposable medical & PPE products
Own 1500 m2 of clean room
Provide OEM service
Annual sales revenue > USD 10 million
ISO 13485 certificated
FDA registered
510K approved (No: K101000)
CE certificated
Our Advantage:
1.FDA, FDA 510K, 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.
Founded in 2006, Wellmien specializes in manufacturing and trading of disposable medical supplies and Personal Protection Equipment (PPE) with more than 300 employees including 8 R&D staff. The sales headquarter is located in Suzhou and manufacturing plant covers an area of 8, 000 square meters among which a 1, 500 square meters of clean room is included.
Our products mainly include face masks, gowns, coveralls, aprons, bouffant caps, shoe covers, sleeve covers, underpads, disposable gloves, wound care products, first aid products and surgical packs, etc., which are widely used in hospitals and food processing industries. The products are widely sold to Europe, North America, South America, Africa and Southeast Asia with annual sales revenue of more than 10 million USD. We provide excellent OEM services according to customer's request.
Wellmien is implementing a strict Quality Management System (QMS) and ISO 13485: 2003 certified. Our main products also have passed CE certification of European Union (EU) and have FDA Medical Device Listing. Wellmien Surgical Masks meet EN14683 standard of EU, and also have acquired FDA 510(K). With superior products and services, our company has won the trust and support from new and old customers.
Pursuit of 'New Products, Better Quality with Better Services' is our shared goal for all Wellmien staff to thrive. We will continue to keep close cooperation with our customers in a broader field, and try our best to provide more high-quality products for the benefit of human health.
YOUR HEALTH IS OUR ETERNAL PURSUIT.
