Biodegradable Products
Biodegradable Products
Bio-Degradable Type II Medical Surgical Mask SPROUT P11E
Bio-Degradable Type II Medical Surgical Mask SPROUT P11E
Bio-Degradable Type II Medical Surgical Mask SPROUT P11E
Bio-Degradable Type II Medical Surgical Mask SPROUT P11E
Bio-Degradable Type II Medical Surgical Mask SPROUT P11E

Type:

3 Ply, Bio-Degradable, Ear-Loop, Hidden BridgeCrossbar

Level:

Type II

PFE:

≥98%

Material:

PLA Non-Woven Fabric,High Fluidity Melt-Blown PLA

Packaging:

10 Pcs, OEM Available

Shelf-life:

12 Months


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Products Details
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Application

KINGFA TYPE II Biodegradable Face Masks providing barrier to minimize the direct transmission of infective agent between staff and patients are principally intended for use by healthcare professionals in an operating room and other medical settings with similar requirements.

 

Protection & Breathability

According to the authoritative TUV test report, the bacterial filtering efficiency of KINGFA biodegradable face masks are above 99.8%, and respiratory resistance is no more than 35Pa, which meets the requirements of TYPE II of the European Union medical masks EN 14683 standard.


Features

●100% Fully Biodegradable PLA

●The MASK provides the same coverage, form, and function as traditional face masks, but in a biodegradable format.

●Made of 3 layer PLA material. Filters at least 98% of particles.

●The bio-degradation test of the nonwoven mask also includes the nose bridge and earloops

●Premium materials ensure mask will not lint or tear.

●Specially designed inner facing improves comfort.

●Skin friendly, odorless, fiber-glass free and latex-free.

●Soft elastic ear loop design can help to fit different human faces

●The adjustable nose bridge clip provides a secure fit for better protection.

●Thin & light multi-layer design reducing respiratory resistance.

 

Quality Standards

●Standard: Type II, EN14683:2019+AC: 2019

Product Classification: Class I Medical Device(Annex VIII of the MDR)

 

Material

Upgraded material for better protection. KINGFA TYPE II Biodegradable Face Masks are made of 3 layers with 2 PLA non-woven layers and a high fluidity melt-blown PLA to absorb small moisture particles. 

 

Biocompatibility

In vitro cytotoxicity Test - Passed
●Delayed Skin Sensitization Test – Passed
●Primary Skin Irritation Test - Passed

                                                                                                      

Technical Specifications

●Bacterial filtration efficiency (BFE): ≥ 98%

●Differential pressure (Pa/cm²) : < 40

●Microbiological Cleanliness(cfu/g)≤2.4mbar

●Breathing resistance(Exhalation, 1600L/min) : ≤30

●Biodegradation Rate:76.71% (in absolute),77.10% (relative to reference material)

 

Logistic Information

●Packaging: 50pcs/box, 50boxes/carton

●Box Size:100*190*80mm,Carton Size:525*395*420mm

●Box Gross Weight:207±10g, Carton Gross weight:11520±500g

 

Container Loading

●20GP:  280 cartons (700,000 units)

●40GP: 600 cartons (1,500,000 units)

●40HQ: 750 cartons (1,875,000 units)

 

OEM Services

Product design and development

Flexible & timely manufacture

Quality control and regulatory compliance

Cost effective with product assurance

Packaging & shipment

Technical support

 

Manufacturing Accreditations

ISO 9001 Quality Management System

ISO 13485 Quality Management System

QSR820 FDA Quality System Requirements

 



Application

KINGFA TYPE II Biodegradable Face Masks providing barrier to minimize the direct transmission of infective agent between staff and patients are principally intended for use by healthcare professionals in an operating room and other medical settings with similar requirements.

 

Protection & Breathability

According to the authoritative TUV test report, the bacterial filtering efficiency of KINGFA biodegradable face masks are above 99.8%, and respiratory resistance is no more than 35Pa, which meets the requirements of TYPE II of the European Union medical masks EN 14683 standard.


Features

●100% Fully Biodegradable PLA

●The MASK provides the same coverage, form, and function as traditional face masks, but in a biodegradable format.

●Made of 3 layer PLA material. Filters at least 98% of particles.

●The bio-degradation test of the nonwoven mask also includes the nose bridge and earloops

●Premium materials ensure mask will not lint or tear.

●Specially designed inner facing improves comfort.

●Skin friendly, odorless, fiber-glass free and latex-free.

●Soft elastic ear loop design can help to fit different human faces

●The adjustable nose bridge clip provides a secure fit for better protection.

●Thin & light multi-layer design reducing respiratory resistance.

 

Quality Standards

●Standard: Type II, EN14683:2019+AC: 2019

Product Classification: Class I Medical Device(Annex VIII of the MDR)

 

Material

Upgraded material for better protection. KINGFA TYPE II Biodegradable Face Masks are made of 3 layers with 2 PLA non-woven layers and a high fluidity melt-blown PLA to absorb small moisture particles. 

 

Biocompatibility

●In vitro cytotoxicity Test - Passed
●Delayed Skin Sensitization Test – Passed
●Primary Skin Irritation Test - Passed

                                                                                                      

Technical Specifications

●Bacterial filtration efficiency (BFE): ≥ 98%

●Differential pressure (Pa/cm²) : < 40

●Microbiological Cleanliness(cfu/g)≤2.4mbar

●Breathing resistance(Exhalation, 1600L/min) : ≤30

●Biodegradation Rate:76.71% (in absolute),77.10% (relative to reference material)

 

Logistic Information

●Packaging: 50pcs/box, 50boxes/carton

●Box Size:100*190*80mm,Carton Size:525*395*420mm

●Box Gross Weight:207±10g, Carton Gross weight:11520±500g

 

Container Loading

●20GP:  280 cartons (700,000 units)

●40GP: 600 cartons (1,500,000 units)

●40HQ: 750 cartons (1,875,000 units)

 

OEM Services

Product design and development

Flexible & timely manufacture

Quality control and regulatory compliance

Cost effective with product assurance

Packaging & shipment

Technical support

 

Manufacturing Accreditations

ISO 9001 Quality Management System

ISO 13485 Quality Management System

QSR820 FDA Quality System Requirements

 




Bio-Degradable Masks Brochure
Bio-Degradable Type II Medical Surgical Mask SPROUT P11E.jpg
Bio-Degradable Masks Chemical Composition Table
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