• Disposable FDA 510K/En14683 Custom Cleaning Medical Face Masks
  • Disposable FDA 510K/En14683 Custom Cleaning Medical Face Masks
  • Disposable FDA 510K/En14683 Custom Cleaning Medical Face Masks
  • Disposable FDA 510K/En14683 Custom Cleaning Medical Face Masks
  • Disposable FDA 510K/En14683 Custom Cleaning Medical Face Masks
  • Disposable FDA 510K/En14683 Custom Cleaning Medical Face Masks

Disposable FDA 510K/En14683 Custom Cleaning Medical Face Masks

Type: Face Mask/Apron/Gloves
Material: Non-woven Fabric
Ethylene Oxide Sterilization: Without Ethylene Oxide Sterilization
Quality Guarantee Period: Two Years
Group: Adult & Child
Logo Printing: With Logo Printing
Samples:
US$ 0/Piece 1 Piece(Min.Order)
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Customization:

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Diamond Member Since 2007

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Rating: 5.0/5
Manufacturer/Factory, Trading Company

Basic Info.

Model NO.
WELLMIEN-FM005
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
Sterile
Nonsterile
Certificate
Ce, ISO 13485, FDA 510(K)
Transport Package
50PCS/Box, 40boxs/CTN
Specification
Adult: 17.5*9.5cm; Child: 14.5*9.5CM
Trademark
WELLMIEN
Origin
Jingsu, China(Mainland)
HS Code
63079000
Production Capacity
9000000PCS/Month

Product Description

HOT PRODUCT
Disposable FDA 510K/En14683 Custom Cleaning Medical Face Masks
Disposable FDA 510K/En14683 Custom Cleaning Medical Face Masks


Disposable FDA 510K/En14683 Custom Cleaning Medical Face 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

 

Disposable FDA 510K/En14683 Custom Cleaning Medical Face Masks
Disposable FDA 510K/En14683 Custom Cleaning Medical Face Masks Disposable FDA 510K/En14683 Custom Cleaning Medical Face Masks

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:
Disposable FDA 510K/En14683 Custom Cleaning Medical Face Masks
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 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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Disposable FDA 510K/En14683 Custom Cleaning Medical Face Masks
Disposable FDA 510K/En14683 Custom Cleaning Medical Face Masks
Disposable FDA 510K/En14683 Custom Cleaning Medical Face Masks

OUR OTHER PRODUCT
Disposable FDA 510K/En14683 Custom Cleaning Medical Face Masks
Disposable FDA 510K/En14683 Custom Cleaning Medical Face Masks
Disposable FDA 510K/En14683 Custom Cleaning Medical Face Masks


 

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