Personal Use Washable Reusable Silver Ion Protective Mask

Product Characteristics

· Non-sterile

· Non-medical

· Bacterial Filtration Efficiency ( BFE ) >90%

· Droplets Against

· Dust Against

· Washable and Reusable

· Optimal Comfort

Product Description:

Product Name Silver Ion Protective Mask
Brand Name St·QANON
Model LN-M04(Folding)
Mask Size
Ingredient Silver ion fiber fabric 54%; Far infrared fiber fabric 28%; Ear loop and nose clip 18%.
Quantity 2 pieces/box
EU Standards
China Standards Complied GB2626-2009
Certificates FDA(Registration Number: 3016748285)
Shelf Life 2 years
Carton Size 232 pieces/ctn
116 boxes/ctn
51*32.8*46.5cm
G.W. 7.65kg/ctn
Volume Weight To be determined
Application Suitable for public health protection. Provides a daily physical isolation of droplet, non-oil particulate, dust, particulate matters(PM), etc.
Usage Apply the mask on your face and hang the loops on ears, press the nose wire to fit your face well.

Added to White List on China Chamber of Commerce for Import and Export of Medicines and Health Products(CCCMHPIE)

Specification Book

Added to White List on China Chamber of Commerce for Import and Export of Medicines and Health Produts(CCCMHPIE)

REPORT

Record of  FDA Official Website

Registration No.：3016748285

Tracking： https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
Owner/Operator Number, Input： 10067007

Medical Device Production License

Translation:

Registration Certificate  No.:粤械注准20202140663
Registration Company Name: Guangzhou Renault Biotechnology Co., Ltd
Registered Address: Room604, North Tower, R&F Ying Li Plaza, No.3-2, Huaqiang Manufacturer Address: Road, Tianhe, Guangzhou, China 51000
1/F No. 3 workshop, 2/F No. 4 workshop, No.6, Xinghong Street, PingShanErChun Industrial Part, Shibi Subdistrict, Panyu District, Guangzhou City, China, 510000
Registration Product Name: Medical Surgical Mask
Registration Product Type: Flat type 17.5cmx9.5cm
Structure and Components: Mask body, ear loop, nose clip. Non-sterile. Disposable.
Application: For clinical and medical staffs use only during invasive operation. It helps clinical and medical staffs cover their mouth, nose and jaw, providing a physical isolation of the direct penetrate of pathogens, microorganisms, body fluids, particles, etc.
Attachment: Technical documents of the product
Others: Non
Remarks: This product is approved in accordance with the Emergency Approval Procedure for the Administrative License of Medicine and Medical Devices Needed for pneumonia caused by novel coronavirus in Guangdong Province. The registration certificate shall be valid for one year. The renewal of registration shall be submitted six months after the expiration of this medical device registration certificate.
Approved by: Guangdong Medical Product Administration
Approved Date: May 22, 2020 Expire Date: May 21, 2021

Medical Device Manufacturing Products Registration Form

Translation:

Registration Company Name: Guangzhou Renault Biotechnology Co., Ltd
Medical Device Production License No：粤食药监械生产许20203686号
License Expire Date: May. 25, 2025
Manufacturing Scope: Class II 14 Injection, infusion, health care and protective equipment- 13 Operating room infection control supplies
Product list: Medical Surgical Mask with registration No.粤械注准20202140663, registered on May 26, 2020.

Approved by: Guangdong Medical Product Administration
Issued Date : May. 26th, 2020

NMPA Record

Medical Device Registration Certificate

Tracking：http://app1.nmpa.gov.cn/datasearchcnda/face3/base.jsp?tableId=26&tableName=TABLE26&title=%B9%FA%B2%FA%C6%F7%D0%B5&bcId=118103058617027083838706701567

Process Control

Test Machine Display

Warehouse for Finished Products