Disposable medical face masks TYPE I, TYPE II and TYPE IIR
Disposable medical face mask produced by our company has three layers: Spunbond (PP) + Meltblown (PP) + Spunbond (PP). CE mark under MDD Class I non-sterile face masks. White List issued by Ministry of Commerce. Type test report issued by TUV Rheinland. 一次性使用非灭菌医用口罩(EN14683:2019),符合欧盟MDD法规自我符合性声明+欧洲主管当局注册,通过商务部以及中国医保商会取得国外注册资质审核,已加入医用口罩出口白名单(医用口罩第65号),由TUV莱茵公司签发的型式检验报告(EN 14683:2019+AC:2019)。
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Disposable Medical Face Masks (Non-sterile, EN14683)

一次性使用非无菌医用口罩(符合EN14683标准)

Specification

产品细节:

1. Name 品名: Disposable medical face mask 一次性使用非无菌医用口罩

2. Application 使用环境: Hospital, dental, clean room, food preparation and industrial environments 医院、洁净室、日常、工业等使用环境

3. Style 样式: Ear-Loops 耳挂式

4. Material 材料:

Inner Coverstock White --25g Polypropylene Spunbonded(SS non-woven) 内侧白色无纺布--25gsm 双S无纺布或20gsm 白色亲肤型无纺布

Middle Filter Medium White --25g Meltblown Filter 中间层熔喷布--25gsm

Outer Coverstock Light Green/Pink/Blue/White --25g Polypropylene Spunbonded(SS non-woven) 外侧蓝色/绿色/粉色/白色无纺布--25gsm 双S无纺布

 

 

Features 产品特点:

1. Soft, Lightweight, comfortable, odorless 柔软,舒适,无异味

2. Form fitting design, Fiberglass free, latex free earloops 贴合脸型,无玻璃纤维,无乳胶

3. No-irritating to skin, permits air passage 无致敏材料,透气性好

 

Package and Shipping 包装和运输:

Packages can be customized according to client's need including the artworks. 包装支持定制

Packing: 5 or 10 or 20 or 25 or 50pcs/box, 2000pcs/CTN 装量:支持1片、5片、10片、20片、25片、50片一个中包装,彩盒支持覆膜,2000只一箱

Choices of middle package: PE bag, OPP bag, Bliser bag or customized 中包装材料:PE袋、自封袋、复合膜袋、吸塑袋、纸塑袋或者定制

Store: Store in dry, humidity below 80%, ventilated, non-corrosive gases warehouse 储存应在阴凉干燥通风处

Shipping: Air, Express, Vessel or Railway transportation. 货运方式:空运、海运、铁路运输

Delivery date: 3 days after placing orders 下单后三天时间(视订单大小)

Daily manufacturing capacity: 2.5 million pcs 日产能:250万只

 

 

 

Qualifications

相关资质:

1. White list No.65 Changzhou Huankang Medical Device Co., Ltd. under Medical Face Masks published by Ministry of Commerce and CHINA CHAMBER OF COMMERCE OF MEDICINES & HEALTH PRODUCTS IMPORTERS & EXPORTERS(CCCMHPIE). 

商务部+中国医保商会出口医用口罩白名单第65位

Link: http://www.cccmhpie.org.cn/Pub/6325/176221.shtml 

 

2. CE MDD Class I Non-sterile disposable face masks (DoC + registration in MHRA)

符合性声明+英国药监局注册:

Link: https://aic.mhra.gov.uk/era/pdr.nsf/vwLkupFileRef/CA017428?opendocument 

3. FDA Registration (510k exempt)

美国FDA:

Owner Number: 10063709

Registered establishment number: 3016757875

Link: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=653706&lpcd=LYU 

 

4. Type test report issued by TUV Rheinland, PONY Test, and SPC for TYPE I, TYPE II and TYPE IIR.

分别由TUV莱茵公司、谱尼测试集团、江苏特防检验中心出具的型式检验报告。

 

Manufacturing Environment for Masks

口罩生产环境:

 

 

 

Workshop for Meltblown Non-woven Filter 熔喷布生产车间:

 

 

 

Workshop for Hot Air Non-woven Fiber (For KN95) 热风棉生产车间(用于KN95):

 

 

 

 

Laboratory 实验室:

 

BFE (细菌过滤效率Bacterial Filtration Efficiency)

 

 

PFE (颗粒过滤效率 Particle Filtration Efficiency)

 

 

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