Disposable FDA 510K/EN14683 Surgical Dental Medical Face Masks
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Product Details
| Customization: | Available |
|---|---|
| Standard: | EN14683-2019 |
| Filter Rating: | 95%-99% |
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Basic Info.
- Model NO.
- WELLMIEN-FM006
- Available Times
- Disposable
- Type
- Face Mask/Apron/Gloves
- Layers
- 3 Ply
- Style
- Earloop
- Shape
- Flat
- Sterilization
- Non Sterilization
- Age Group
- Adult
- Color
- White/Blue/Green/Yellow etc.
- Size
- Adult: 17.5*9.5cm / Child: 14.5*9.5cm
- Layer
- 3ply
- Nose Clip
- Single Nose Wire/Double Nose Wire/Plastic Nose Cli
- Certificate
- Ce, ISO 13485, FDA 510(K)
- Sterile
- Nonsterile
- Material
- Non-woven Fabric
- Certification
- CE, FDA, ISO13485
- Ethylene Oxide Sterilization
- Without Ethylene Oxide Sterilization
- Quality Guarantee Period
- Two Years
- Logo Printing
- With Logo Printing
- Group
- Adult & Child
- Transport Package
- 50pcs/box, 40boxes/CTN
- Specification
- Adult: 17.5*9.5cm; Child: 14.5*9.5cm
- Trademark
- WELLMIEN OR OEM
- Origin
- Jiangsu, China(Mainland)
- HS Code
- 63079000
- Production Capacity
- 9000000PCS/Month
Product Description
Disposable FDA 510K/EN14683 Surgical Dental Medical Face Masks
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:
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:
Shipping Port: Shanghai or Wuhan.
Packing Picture:
If you like, you can choose other styles of masks:
Supporting protective equipment (simple protective bag)
| 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)
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