• Wholesale Disposable 3 Ply Non Woven Surgical Medical Face Mask
  • Wholesale Disposable 3 Ply Non Woven Surgical Medical Face Mask
  • Wholesale Disposable 3 Ply Non Woven Surgical Medical Face Mask
  • Wholesale Disposable 3 Ply Non Woven Surgical Medical Face Mask
  • Wholesale Disposable 3 Ply Non Woven Surgical Medical Face Mask
  • Wholesale Disposable 3 Ply Non Woven Surgical Medical Face Mask

Wholesale Disposable 3 Ply Non Woven Surgical Medical Face Mask

Type: Surgical Supplies Materials
Material: Non-woven Fabric
Ethylene Oxide Sterilization: Without Ethylene Oxide Sterilization
Quality Guarantee Period: Five Years
Group: Adult
Logo Printing: With Logo Printing
Samples:
US$ 0/Piece 1 Piece(Min.Order)
| Request Sample
Regular samples are free, 10 pieces can be provide
Customization:
Diamond Member Since 2007

Suppliers with verified business licenses

Rating: 5.0/5
Manufacturer/Factory, Trading Company

Basic Info.

Model NO.
WELLMIEN-FM0036
Color
White, Green, Blue ..
Style
Earloop
Size
17.5*9.5cm
Function
Protection for Operation
Classify
Bfe 99% 3ply Ear-Loop Pleated Surgical Face Mask
Application
Hospital, Medical, Dental, Daily Use
Transport Package
50PCS/Box, 40boxes
Specification
CE, ISO13485
Trademark
WELLMIEN or OEM
Origin
Jiangsu
HS Code
6307900090
Production Capacity
6, 000, 000 Pieces / Month

Product Description

HOT PRODUCT
Wholesale Disposable 3 Ply Non Woven Surgical Medical Face Mask
Wholesale Disposable 3 Ply Non Woven Surgical Medical Face Mask


Wholesale disposable 3 ply non woven surgical medical face mask
 
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

Wholesale Disposable 3 Ply Non Woven Surgical Medical Face MaskWholesale Disposable 3 Ply Non Woven Surgical Medical Face MaskWholesale Disposable 3 Ply Non Woven Surgical Medical Face Mask

 

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:
Wholesale Disposable 3 Ply Non Woven Surgical Medical Face Mask
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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Wholesale Disposable 3 Ply Non Woven Surgical Medical Face Mask
Wholesale Disposable 3 Ply Non Woven Surgical Medical Face Mask
Wholesale Disposable 3 Ply Non Woven Surgical Medical Face Mask

OUR OTHER PRODUCT
Wholesale Disposable 3 Ply Non Woven Surgical Medical Face Mask
Wholesale Disposable 3 Ply Non Woven Surgical Medical Face Mask
Wholesale Disposable 3 Ply Non Woven Surgical Medical Face Mask

 

 
 

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Diamond Member Since 2007

Suppliers with verified business licenses

Rating: 5.0/5
Manufacturer/Factory, Trading Company
Plant Area
>2000 square meters
Management System Certification
ISO 13485