[product name] Medical protective Mask
[Executive standard] EN 14683:2019
The company has passed ISO 13485:2016 and ISO 9001:2015 certification.
［Structure Composition] The product is made up of Mask body, nose bridge hold and Mask belts.The Mask body is inner, middle and outer.The outer layer and inner layer are non-woven fabric,the middle layer is melt blown non-woven fabric,the Mask belts are polyester elastic belts,and the nose bridge hold is made of metal strip, which is made of thin galvanized iron wire and plastic.
1.The bacterial filtration efficiency of the Mask shall not be less than 95%;
2.The filtering efficiency of Mask to non oil particles shall not be less than 30%;
3.The pressure difference Δ p between the two sides of the Mask for gas exchange shall not be greater than 49Pa / c㎡;
4.The Mask material shall be non combustible, and the burning time of the Mask after leaving the flame shall not be more than 5s;
5.Sterilize with ethylene oxide and the residual amount of ethylene oxide shall not exceed 10μ g/g;
6. Masks should be sterile.
It is used in the medical working environment, it can be used to filter the particles in the air, block the droplets, blood, body fluids, secretions, etc. it can ñot be used to isolate the ICU room and other places with strict microbial index control requirements.
1.Open the Mask and hold it on your face with your hands, with the nose clip on top.
2.Pull the ear loops over your ears and adjust Mask so that it covers your nose and chin.
3.Adjust the nose clip to the shape of the bridge of the nose to make a good seal.
4.To check fit, cup both hands over the Mask and exhale vigorously. If air flows around nose, tighten the nose clip. If air leaks around the edge, reposition the ear loops for better fit. Recheck the seal and repeat the procedure until the Mask is sealed properly. If you cannot get a good seal, we suggest you use a different Mask.
5.Please replace the product with a new one after 4 hours of use.
6. Disposable, destroyed after use.
1.In case of dizziness, nausea and dyspnea during use, please leave the infected area and replace the product immediately:
2.Please destroy the product after use and prohibit reuse;
3.Check the suitability of the Mask before using the product. If it is not suitable, please replace it. If there is hair in the edge of the Mask, the requirement of tightness may not be met;
4.The medical protective Mask is a disposable product. Please check the packing bag carefully before use. If the packing bag is damaged, it is strictly prohibited to use it;
5.Before using the product, please read the manual carefully and check the production batch number / production date. It is not allowed to use the product beyond the time limit;
6.The product shall be used as soon as possible after opening.
［Contraindications] It is forbidden for those who are allergic to this product.
［Transportation and Storage] The transportation means should be clean and isolated from fire source. The product should be stored in a dry, cool ahnd clean room, away from direct sunlight, without corrosive gases and with good ventilation. It is strictly prohibited to store with toxic or hazardous substances.
［Sterilization Method] The product is sterilized with ethylene oxide gas.
［Service life] 2 years after sterilization with ethylene oxide.
［Manufacture Date] See packaging
Shandong Zhushi Pharmaceutical Group Co.,Ltd
ADD:No.6 Shande Road,Shan County,Heze City,Shandong,China 274300
Tel: +86-13256133668 Email: email@example.com
［Product technical requirement NO.JLUXIEZHUZHUN20202140312
［Standard] GB 19083-2010
［Production license NO.]
The company has passed ISO 13485:2016 and ISO 9001:2015 certification
MedNet EC-REP GmbH
Borkstrasse 10, 48163 Münster,Germany