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Factory Outlets Face Mask Earloop 3 Ply - 5 ply KN95 Medical face mask – EISEN

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Factory Outlets Face Mask Earloop 3 Ply - 5 ply KN95 Medical face mask – EISEN Detail:

Quick Details

Type:medical mask

Applicable People:Adult

Standard:EN14683 Type II

Filter Rating:98

Place of Origin:Guangdong, China

Brand Name:Moen Or OEM

Model Number:KN95

Size:155*105mm

Shelf Life:2 years

Safety standard: GB19083-2010

Instrument classification:Class II

MOQ:10000PCS

Product name:5 ply KN95 face mask

 

Supply Ability

Supply Ability:100000 Piece/Pieces per Day

 

Packaging & Delivery

Packaging Details: carton packing

Packing: 5 pieces /bag, 25 pieces / box,50 boxes/ carton,1000 pieces / carton

Port: Shenzhen port

Specification

Item discription: 5 ply kn95 face mask

Unit size: 155*105mm

China government approval: yes, we are on the white list

Delivery:3-7Working Days

 

TEST REPORT EN 14683:2019 Medical face masks Requirements and test methods

Report reference No. AST2003205049

Test By: Megan

Approved By: Thomas

Date of issue: 2020-04-11

Date of test: 2020-03-30 to 2020-04-11

Testing laboratory: Aerospace Testing Technology (Shenzhen) Co., Ltd.

Location: 3/F, Block A1, No. 5, 8th Road, Shapu Yangyong Industrial Park, Songgang Street, Bao’an District, Shenzhen, Guangdong, China

Applican: DONGGUAN TENSUM HEALTH &TECHNOLOGY CO.,LTD

Address: Room 501,building 1,No.1 Dongyuanwulu Road,lianhu, Tangxia Town,Dongguan city, Guangdong, China.

Standards EN 14683:2019

Type of test product: KN95 Medical face mask

Model/Type designation: 604A-01

Test procedure: MDD Approval

EN 14683:2019

 

Clause Requirement + Test Verdict
3.1 aerosol gaseous suspension of solid and/or liquid particles P
3.2 bacterial filtration efficiency (BFE) efficiency of the medical face mask material(s) as a barrier to bacterial penetration 3.2 Note 1 to entry: The BFE test method is used to measure the bacterial filtration efficiency (BFE) of medical face mask materials. P
3.3 biocompatibility quality of being accepted in a specific living environment without adverse or unwanted side effects P
3.4 cleanliness freedom from unwanted foreign matter P
3.4.1 microbial cleanliness freedom from population of viable micro-organisms on a product and/or a package p
3.5 colony forming unit (CFU) unit by which the culturable number of micro-organisms is expressed  Note 1 to entry: The culturable number is the number of micro-organisms, single cells or aggregates, able to form colonies on a solid nutrient medium. P
3.6 differential pressure air permeability of the mask, measured by  determining the difference of pressure across the mask under specific conditions of air flow, temperature and humidity P
3.7 filter material used for mechanical and physical  separation or deposition of aerosol particles (liquid or solid) from the inhaled and exhaled air N/A

 

3.8 infective agent micro-organism that has been shown to cause surgical wound infections or that might cause infection in the patient, members of staff or other P
3.9 medical face mask medical device covering the mouth and nose providing a barrier to minimize the direct transmission of infective agents between staff and patient P
3.10 splash resistance ability of a medical face mask to withstand penetration of synthetic blood projected at a given pressure P
3.11 surgical procedure surgical intervention penetrating skin or mucosa, performed by a surgical team under controlled environmental conditions NA
4.0 Classification Medical face masks specified in this European Standard are classified into two types (Type I and Type II) according to bacterial filtration efficiency whereby Type II is further divided according to whether or not the mask is splash resistant. Type II       P
5.0 Requirements P
5.1 General P
5.1.1 Materials and construction The medical face mask is a medical device, generally composed of a filter layer that is placed, bonded or moulded between layers of fabric. The  medical face mask shall not disintegrate, split or tear during intended use. In the selection of the filter and layer materials, attention shall be paid to cleanliness absence of particulate matter P

 

5.1.2 Design The medical face mask shall have a means by which it can be fitted closely over the nose, mouth and chin of the wearer and which ensures that the mask fits closely at the sides.  Medical face masks may have different shapes and constructions as well as additional features such as a face shield (to protect the wearer against splashes and droplets) with or without anti-fog function, or a nose bridge (to enhance fit by conforming to the nose contours) Metal strip fixing   P
5.2 Performance requirements P
5.2.1 General All tests shall be carried out on finished products or samples cut from finished products, if applicable in their sterile state. P
5.2.2 Bacterial filtration efficiency (BFE) When tested in accordance with Annex B, the bacterial filtration efficiency (BFE) of the medical face mask shall conform to the minimum value given for the relevant type in Table 1. Bacterial filtration efficiency (%), 98.8      P
5.2.3 Breathability When tested in accordance with Annex C, the differential pressure of the medical face mask shall conform to the value given for the relevant type in Table 1. Differential pressure (Pa/cm 2 ), 33.25 Pa/cm 2 < 40 Pa/cm 2P
5.2.4 Splash resistance When tested in accordance with ISO 22609 the resistance of the medical face mask to penetration of splashes of liquid shall conform to the minimum value given for Type IIR in Table 1. NA
5.2.5 Microbial cleanliness (Bioburden) When tested according to EN ISO 11737-1 thecfu/g tested (see Table 1). NOTE EN ISO 11737-1 specifies requirements and provides guidance for the enumeration and microbial characterisation of the population of viable microorganisms on or in a medical device, component, raw material or package.EN ISO 11737-1, follow the procedure below: The number of masks that shall be tested is minimum 5 (five), but can be greater if necessary to allow for an AQL of 4 %.  NA
5.2.6 Biocompatibility According to the definition and classification in EN ISO 10993-1, a medical face mask is a surface device with limited contact. The manufacturer shall complete the evaluation of the medical face mask according to EN ISO 10993-1 and determine the applicable toxicology testing regime. The results of testing should be documented according to the applicable parts of the EN ISO 10993 series. The test results shall be available upon request. As a minimum, EN ISO 10993-5 and EN ISO 10993-10 shall be considered. P

 

6 Labelling and information to be supplied P
  The following information shall be supplied in addition: a) number of this European Standard; b) type of mask (as indicated in Table 1). EN 14683:2019 Type II       P
Annex A Information for users P
  When breathing, speaking, coughing, sneezing etc., one releases smaller or larger amounts of droplets of secretions from the mucous membranes in the mouth and nose. The majoritydiameter and especially the larger droplets can contain micro-organisms from the source site. Nuclei can subsequently spread through the air to a susceptible site such as an open operating wound or sterile equipment.  P
Annex B Method for in-vitro determination of bacterial filtration efficiency (BFE) P

Product detail pictures:

Factory Outlets Face Mask Earloop 3 Ply - 5 ply KN95 Medical face mask  – EISEN detail pictures

Factory Outlets Face Mask Earloop 3 Ply - 5 ply KN95 Medical face mask  – EISEN detail pictures


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