FDA 510K/En14683 Decorated Surgical Masks

• Customization: Available
• Standard: EN14683-2019
• Filter Rating: Normal
• Model NO.: WELLMIEN-FM082
• 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, 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

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FDA 510K/En14683 Decorated Surgical Masks

 

Style	earloop
Size	17.5*9.5cm
Material	3ply: SBPP,MB, SBPP
Certification	FDA 510K, CE, ISO13485
Structure	without face visor
Type	without soft foam
Nose clip	double wire

 

Specification:

1.Conform to FDA 510K (No:K101000).

2. Glass fiber-free and latex-free.

3. Breathing Resistance (Delta P)<6.0.<>

4.Bacterial Filtration Efficiency (BFE%) >99%

5.Particle Filtration Efficiency(PFE%)>99%.

6. Synthetic Blood Penetration Resistance: 160mmHg.
 

Packing:

Normal Packing	QTY (pc)	Carton Size (cm)	N.G (kg/ctn)	W.G (kg/ctn)	Prodution 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.

Wellmien Performance for Surgical Face Mask ASTM Level 3 Non Woven FDA510K:

Standard Class	Breathing Filtration Efficiency (BFE)	Breathing Resistance (mmH20/cm2)	Splash Resistance (mmHg)	Particulate Filtration Efficiency (PFE)
FDA 510K ASTM F 2100 Level 3	>99%	< 6,0	160	>99%

Shipping Port: Shanghai or Wuhan.

Packing Picture:

Remark: To better ensure the safety of your goods, professional, environmentally friendly, convenient and efficient packaging services will be provided.

FDA 510 K Requirements:

MEDICAL FACE MASK TESTS AND REQUIREMENTS U.S.A.: ASTM F2100-19 STANDARD SPECIFICATION FOR PERFORMANCE OF MATERIALS USED IN MEDICAL FACE MASKS
Test Item		ASTM F2100-19
		Level 1	Level 2	Level 3
Barrier Testing	BFE% ASTM F2101	≥95	≥98
	PFE% ASTM F2299	≥95	≥98
	Synthetic Blood ASTM F1862	Pass at 80mmHg	Pass at 120mmHg	Pass at 160mmHg
Physical Testing	Differential Pressure	<5.0 mmh2o="">	<6.0 mmh2o="">
Safety Testing	Flammablility 16 CFR Part 1610	Class 1 (≥ 3.5 seconds)
	Microbial Cleanliness ISO 11737-1	Not required
	Biocompatibility ISO 10993	510 K Guidance recommends testing to ISO 10993
Sampling ANSI/ASQC Z1.4 ISO 2859-1		1. AQL 4% for BFE,PFE, Delta P 2. 32 masks for Synthetic Blood (Pass=≥29 passing, Fail=≤28 passing) 3. 14 masks for Flammability

<5.0 mmh2o=""><6.0.<><5.0 mmh2o=""><6.0 mmh2o=""><6.0 mmh2o="">[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.

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