Medical Face Masks
Product size & Type 175mm*95mm 175mm*95mm non-sterile Plain with ear straps type
Production license number (Min) Pharmaceutical Supervision Machinery Production No. 20200459 (provisional)
Medical device registration certificate number / product technical requirement number(Min) Medical device registration No. 20202140073 (provisional)
Production composition and componentsIt is non-sterile product composed by mask cover,nose bridge and ear straps, mask cover is combined by 3 layers of Non-woven include Spunbond and Meltblown non-woven,ear straps made by elastic film or elastic band.
Main function indicator standards
with nose strap made by malleable material, length ≥8cmThe break strength of ear strip and mask joint should be not less than 10NSynthetic blood penetration: with 2mL of synthetic blood is sprayed at the pressure of 16.0kPa (120mmHg) towards the outer side of the mask, no penetration should occur on the inner side of the masks .Filtration efficiency: bacterial filtration efficiency is not less than 95%, particle filtration efficiency is not less than 30% (for non-oily particles);
5)Pressure difference: the pressure difference △ p for air exchange between the two sides of the mask should not be greater than 49 Pa;
6)Flame retardant:with non-flammable material:burn no more than 5 seconds after leaving the flame.
7))Microbiological index:total number of baterial colonies ≤100 CFU/g.
Application: For clinical medical personnel to wear during the invasive operation, covering the user's mouth, nose and jaw, to provide a physical barrier to prevent direct transmission of pathogenic microorganisms, body fluids, particles, etc.
Contraindications:Nor yet found.
Storage condition:This product should be stored in a cool,dry, non-corrosive gas, well-ventilated and clean environment.
Precautions, warnings and informational content:
Please read the instructions carefully to avoid touching the inner layer of the mask with your hands;This is a non-medical mask, do not use under strict Microbiological control environment.Do not use,if the packaging is damaged.This product is for one-time use, do not repeated use; Please change masks in time if there are liquid splashing, damage, dampness and breathing resistance obviously increase during wearing. After the product is used, please deal with it under the requirements of the hospital or environmental protection department.
Instructions for use
Please read the instructions carefully to avoid touching the inner layer of the mask with your hands;Please check the packaging before use and do not use if the packaging is damaged;
3) This product is for one-time use, do not repeated use;
4) After the product is used, please deal with it under the requirements of the hospital or environmental protection department.
Production batch number: See the code on package
Valid Date: 18 months
Business Site:No.1,Xinqiang Road,Machinery Printing Base,Gaoxin District,Hongshan Town,Shishi City,Fujian Province,China
Manufacturer address:No.1,Xinqiang Road,Machinery Printing Base,Gaoxin District,Hongshan Town,Shishi City,Fujian Province,China