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

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

Overview White Listing FDA510K ASTM Level 3 Disposable Nonwoven Medical Surgical Face Mask for Single-Use Product Descri;
Overview
Basic Info.
Model NO. WELLMIEN-SM002
Shape Flat
Sterilization Non Sterilization
Age Group Adult
Color White, Sky Blue, Yellow, Pink
Quality Guarantee Period Three Years
Ethylene Oxide Sterilization Without Ethylene Oxide Sterilization
Logo Printing Customized
Group Both
Material Non-woven Fabric
Certification CE, FDA, ISO13485
Usage Laboratory, Clinic, Food Processing, Hospital, etc
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

Styleearloop
Size17.5*9.5cm
Material3ply: SBPP,MB,SBPP
CertificationFDA 510K, CE, ISO13485
Structurewithout face visor
Typewithout soft foam
Nose clipdouble 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-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

Packaging & Shipping

Packing:

Normal PackingQTY
(pc)
Carton Size
(cm)
N.G
(kg/ctn)
W.G
(kg/ctn)

Prodution Time
(day)

50pcs/box
40boxes/ctn
200,00052X40X367.58.510
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 ItemASTM F2100-19
Level 1Level 2Level 3
Barrier TestingBFE%
ASTM F2101
≥95≥98
PFE%
ASTM F2299
≥95≥98
Synthetic Blood
ASTM F1862
Pass at 80mmHgPass at 120mmHgPass at 160mmHg
Physical TestingDifferential Pressure<5.0 mmH2O/cm³<6.0 mmH2O/cm³
Safety TestingFlammability
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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