En14683/FDA 510K High Level Disposable Medical Use 3ply Non-Woven Face Mask with Earloop

• Customization: Available
• Type: Face Mask/Apron/Gloves
• Material: Non-woven Fabric
• Model NO.: WELLMIEN-FM031
• 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 Description

En14683/FDA 510K High Level Disposable Medical Use 3ply Non-Woven Face Mask with Earloop
 

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:

1. 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.
2. 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;
3. Adjust the mask belt appropriately according to personal comfort.

How to remove 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:

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)