• White Listing FDA510K ASTM Level 3 Disposable Nonwoven Medical Surgical Face Mask for Single-Use
  • White Listing FDA510K ASTM Level 3 Disposable Nonwoven Medical Surgical Face Mask for Single-Use
  • White Listing FDA510K ASTM Level 3 Disposable Nonwoven Medical Surgical Face Mask for Single-Use
  • White Listing FDA510K ASTM Level 3 Disposable Nonwoven Medical Surgical Face Mask for Single-Use
  • White Listing FDA510K ASTM Level 3 Disposable Nonwoven Medical Surgical Face Mask for Single-Use
  • White Listing FDA510K ASTM Level 3 Disposable Nonwoven Medical Surgical Face Mask for Single-Use

White Listing FDA510K ASTM Level 3 Disposable Nonwoven Medical Surgical Face Mask for Single-Use

Standard: ASTMF2100
Filter Rating: Bfe99% or Bfe98%
Available Times: Disposable
Type: Medical Surgical Mask
Layers: 3 Ply
Style: Earloop
Samples:
US$ 0/Piece 1 Piece(Min.Order)
| Request Sample
Blue, Pink or as customized
Customization:
Diamond Member Since 2007

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Rating: 5.0/5
Manufacturer/Factory, Trading Company
  • Overview
  • Product Description
  • Detailed Photos
  • Packaging & Shipping
  • Product Parameters
  • Applications
  • One-stop shopping
Overview

Basic Info.

Model NO.
WELLMIEN-SM002
Shape
Flat
Sterilization
Non Sterilization
Age Group
Adult
Color
White, Sky Blue, Yellow, Pink
Usage
Laboratory, Clinic, Food Processing, Hospital, etc
Material
Non-woven Fabric
Certification
CE, FDA, ISO13485
Ethylene Oxide Sterilization
Without Ethylene Oxide Sterilization
Quality Guarantee Period
Three Years
Group
Both
Logo Printing
Customized
Transport Package
50PCS/Box, 40boxes/CTN
Specification
17.5X9.5cm(Adult); 14.5X9.5cm(Child)
Trademark
WELLMIEN
Origin
China, Jiangsu
HS Code
63079000
Production Capacity
9000000

Product Description

White Listing FDA510K ASTM Level 3 Disposable Nonwoven Medical Surgical Face Mask for Single-Use

Product Description

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.
 

Detailed Photos

White Listing FDA510K ASTM Level 3 Disposable Nonwoven Medical Surgical Face Mask for Single-UseWhite Listing FDA510K ASTM Level 3 Disposable Nonwoven Medical Surgical Face Mask for Single-Use

White Listing FDA510K ASTM Level 3 Disposable Nonwoven Medical Surgical Face Mask for Single-Use

Packaging & Shipping

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.

 

Shipping Port: Shanghai or Wuhan.

Packing Picture:
White Listing FDA510K ASTM Level 3 Disposable Nonwoven Medical Surgical Face Mask for Single-Use
Remark: To better ensure the safety of your goods, professional, environmentally friendly, convenient, and efficient packaging services will be provided.

 

Product Parameters

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%

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/cm³ <6.0 mmH2O/cm³
Safety Testing Flammability
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

Applications

[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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White Listing FDA510K ASTM Level 3 Disposable Nonwoven Medical Surgical Face Mask for Single-Use
White Listing FDA510K ASTM Level 3 Disposable Nonwoven Medical Surgical Face Mask for Single-Use
White Listing FDA510K ASTM Level 3 Disposable Nonwoven Medical Surgical Face Mask for Single-Use

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White Listing FDA510K ASTM Level 3 Disposable Nonwoven Medical Surgical Face Mask for Single-Use
White Listing FDA510K ASTM Level 3 Disposable Nonwoven Medical Surgical Face Mask for Single-Use
White Listing FDA510K ASTM Level 3 Disposable Nonwoven Medical Surgical Face Mask for Single-Use

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White Listing FDA510K ASTM Level 3 Disposable Nonwoven Medical Surgical Face Mask for Single-Use
White Listing FDA510K ASTM Level 3 Disposable Nonwoven Medical Surgical Face Mask for Single-Use



 

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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