PFE 99.9% BFE 99.9% ASTM Level 3 Type IIR GreenGuard premium medical mask (FDA,CE)

Passed ASTM Level 3 test, Passed EN14683 Type 2R test, Passed Biocompatibility test, FDA Class 1 & 2, CE MDD 1 Type IIR, ISO13485


Negotiable Min Order Quantity Unit

Required Quantity
Place of Origin
South Korea
Brand name
GreenGuard
Payment Terms
T/T
Production method
OBM,ODM
Shipping / Lead Time
Negotiable / Negotiable
Keyword
medical mask, surgical mask, astm level 3, type iir
Category
Medical Face Mask , Nebulizer & Mask , Other Respiratory Equipment , Other Surgical Equipment
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Guard Call Co., Ltd.

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VIP
Country / Year Established
South Korea South Korea / 2020
Business type
Manufacturer
Verified Certificate

3

DUNS

ISO

Product name PFE 99.9% BFE 99.9% ASTM Level 3 Type IIR GreenGuard premium medical mask (FDA,CE) Certification FDA , CE
Category Medical Face Mask
Nebulizer & Mask
Other Respiratory Equipment
Other Surgical Equipment
Material IRON WIRE,MELT BLOWN FILTER,NYLON & POLYESTER,PP SPUNBOND NON WOVEN FABRIC,THERMAL BONDED FABRICS
Keyword medical mask , surgical mask , astm level 3 , type iir Unit Size -
Brand name GreenGuard Unit Weigh -
origin South Korea Stock 100000
Supply type OBM,ODM HS code 63079040

Product Information

- Had passed ASTM F2100 test for level 3, the highest level for mask for FDA in the U.S.

- Had passed CE MDD1. EN14683 test for Type IIR, the highest level for medical mask for CE in Europe

- Had passed Biocompatibility test

 

- Had acquired ISO 13485 Certificate.

- Had acquired KFDA in Korea for medical mask.

- Had acquired CE MDD 1 EN14683 Type IIR.

- Had registered FDA class I & II.

 

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For Hygienic and Convenient Use : "INDIVIDUAL PACKING" is possible according to customer's demand.

2PCS/PACAGE  &  30PCS(15packages)/BOX

When you go out, you can prepare all just by picking One package!!

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GreenGuard premium color/medical mask is different from other mask ; 

 

Point 1 : "High protection"(BFE>99.9% & PFE>99.9%) from corona viruses. It helps you keeping you and your loving people from viruses.

Point 2 : "Very breathable" mask. It provides comfortable breath when you wearing it.

Point 3 : "Various colors." You can choose the colors depending on your style, mood, and condition. Different from other color mask, the color quality is also good.(not blurry)

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Colors : Violet, Pink Blush, Yellow, White, Royal Blue, Sand Beige, Soft Grey, Others(according to custmer's demand)

1. Passed ASTM F2100 Level 3 Test

 

(1) Bacteria Filtration Efficiency Test (BFE)

 

The result of BFE for GreenGuard premium mask shows that BFE of all samples tested is over 99.95%. The BFE measures the filtration efficiency of masks using live bacteria of size 0.3 microns. This means that this GreenGuard mask blocks 0.3micro particles(including viruses) over 99.95%.

 

 

(2) Sub-micron particulate filtration efficiency(PFE)

 

The result of PFE test shows that PFE of all samples is over 99.95%.

 

This test measures the filtration efficiency of a mask using nonviable particles that are fixed in size from 0.1 micron.(which is smaller than the size of corona-viruses). This means that this GreenGuard mask blocks 0.1micro particles(including viruses) over 99.95%. By wearing it, customers can keep themselves from corona-viruses over 99.95%.

 

 

(3) Differential Pressure(DP)

 

The average of DP for GreenGuard mask is approxi. 4.0Pa/cm2.

 

Differential Pressure test is a test that can measure how comfortable a person wearing a mask can breathe. By measuring how easily air is passed from one side of the mask to the other, this indicates how easily the wearer can breathe through the mask, and is in indicated by DP. Higher DP indicates air is more difficult to push through(hard to breathe). The result of DP for GreenGuard mask is 4.0Pa/cm2 which is much lower than the criteria of ASTM level 3.(provides very comfortable breathe.)

 

 

(4) Resistance to penetration by synthetic blood

 

All 32 samples of GreenGuard mask used in this test passed.

 

This test is performed to determine a product’s ability to act as a barrier to blood-borne pathogens. The resistance to penetration by synthetic blood test method challenges medical face masks with a fixed volume of synthetic blood directed at high velocity at the center of the mask.(For ASTM Level 3 test, 160mmHg is required.) 2 ml of synthetic blood is sprayed through a small cannula onto the surface of the mask. If this liquid does not pass through the mask, it has passed this test. Passing this test means that it is a mask that can protect patients and medical staff very safely from splashing saliva and blood during surgery.

 

 

(5) Flammbility

 

The result of flammability test is “Class 1” which means that it exhibits normal flammability and are acceptable for use in clothing.

 

 

2. Passed the Biocompatibility Test (ISO 10993-5, ISO 10993-10)

 

The result of this test shows that GreenGuard mask is not cytotoxic nor irritative.

This test assesses the compatibility of medical mask with a biological system. It studies the interaction between the device and the various types of living tissues and cells that are exposed to the device when it comes into contact with patients.


3. Passed EN14683 test for Type IIR (Type 2R)


Similar result with the ASTM level 3 test.


For all samples, the result for BFE test is 100%

 

 

Biocompatibility test passed

BFE > 99.9%

PFE > 99.9%

DP < 40 Pa (5.0Pa)

Resistance to penetration by synthetic blood - passed.

flammbility test passed

Bioburden test passed

 

Verified Certificate

FDA

CE

B2B Trade

Price (FOB) Negotiable transportation Air Transportation,Express,Land Transportation,Negotiation Other,Ocean Shipping
MOQ Negotiable Leadtime Negotiable
Payment Options T/T Shipping time Negotiable

Guard Call Co., Ltd.

Country / Year Established
South Korea South Korea / 2020
Membership
VIP
Business type
Manufacturer

3

DUNS

ISO

President
Siyeon Park
Address
33 Jinheungro 38beongil, Danwon-gu, Ansan-si, Gyeonggi-do, Korea
Product Category
Medical Face Mask,Nebulizer & Mask
Year Established
2020
No. of Total Employees
1-50
Company introduction

Mask manufacturing Company in South Korea.

 

the ASTM level 3 surgical mask

Type IIR surgical mask

ISO 13585

Main Markets

Hong Kong(China) Hong Kong(China)

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