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Ce and FDA 510K Approved Disposable Non-Woven Surgical Masks
Ce and FDA 510K Approved Disposable Non-Woven Surgical Masks
Ce and FDA 510K Approved Disposable Non-Woven Surgical Masks
Ce and FDA 510K Approved Disposable Non-Woven Surgical Masks
Ce and FDA 510K Approved Disposable Non-Woven Surgical Masks
Ce and FDA 510K Approved Disposable Non-Woven Surgical Masks

Ce and FDA 510K Approved Disposable Non-Woven Surgical Masks

Min.Order: 200,000
Product origin: Suzhou, Jiangsu, China
Infringement complaint: complaintComplaint
US$ 0.018 ~ 0.025

Description
HOT PRODUCT


Ce and FDA 510K Approved Disposable Non-Woven Surgical Masks
 
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.
 

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.

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 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=""><6.0 mmh2o="">
Safety TestingFlammablility
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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