Product Name: ASTM Level3 Flat Type 3 layers Surgical Mask
Brand Name: St·QANON
Model: LN-YWL3
Mask Size: Flat Type 17.5cm*9.5cm
Ingredient: Non-woven fabric 67%; Melt-blown fabric 22%; Ear loop and nose clip 11%.
Quantity: 50 pieces/box(10pieces/bag, 5bags/box)
US Standards: ASTM Level3
China Standards: Complied YY 0469-2011《医用外科口罩》
Certificates: CE/FDA(Registration Number: 3016748285)
Shelf Life: 2 years
Carton Size: 2500 pieces/ctn50 boxes/ctn52*45*58cm
G.W.: 12kg/ctn
Volume Weight: Appr. 21kg/ctn
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.
Usage:
1. Position the colored side of the mask outward, make sure the nose clip is at the front of the mask and position ed against the bridge of your nose.
2. Hold the mask by both ear loops and place one loop over each ear.
3. Mold the bendable nose clip to the shape of your nose by pinching and pressing down it with your fingers.4. Pull the bottom of the mask over your mouth and chin, ensure the mask fit snugly.
Core Technical Parameters
Tracking: http://en.cccmhpie.org.cn/Web/Content.aspx?queryStr=w7x08q7x15x15o3w8w1vS9z8w7x1X10x16x0X10x16o3w8w1u9v1u9vV0u9
Tracking: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
Owner/Operator Number, Input: 10067007
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
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
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