TEL/WhatsApp:+086 13256133668
Product Detail
disposable medical face mask,EN14683:2019 Type IIR,Export to Russia
Detail
Price(价格): 0.031EUR Brand(品牌): ZS
Spec(规格): 17.5cm*9.5cm Model: ZS-A
certification: SGS

3ply with Earloop

Size:17.5*9.5cm

Disposable Medical face mask

Sterile/Non-Sterile

EN 14683:2019 Type IIR

ISO 13485、ISO9001

WhatsApp:+86 13256133668

MEETS EN14683:2019 REQUIREMENTS FOR MEDICAL MASKS BFE≥98%

The company has passed ISO13485:2016 certfication

EN TYPE IIR医用灭菌.jpg

[product name] disposable medical face mask (non surgical)

[model] sterile type

[Specification] 17.5cm × 9.5cm, 17.5cm × 9.0CM, 17.0cm × 9.0CM, 14.5cm × 9.5cm, 12.5cm × 9.0CM, 12.0cm × 7.0cm

口罩带电话2.png

[structure composition] this product is composed of non-woven fabric, nose strip and rubber band. The mask body is divided into three layers: inner layer, middle layer and outer layer. The inner layer is ordinary non-woven fabric, the middle layer is superfine polypropylene fiber melt blown fabric, and the outer layer is non-woven fabric. The mask belt is made of rubber band and wrapped with non-woven fabric; the nose strip is made of metal strip with fine galvanized iron wire wrapped with plastic. According to whether sterile supply is divided into sterile type and non sterile type, disposable.

[performance index] the breaking strength of the connection point between each mask belt and the mask body should not be less than 10N; the bacterial filtration efficiency of the mask should not be less than 95%; the ventilation resistance of the two sides of the mask for gas exchange should not be greater than 49pa / cm; the residual ethylene oxide content of the sterile mask should not exceed 10 μ g / G after being sterilized by ethylene oxide;

[scope of application] it is worn by all kinds of clinical personnel in the process of non-invasive operation, covering the mouth, nose and jaw of the user, so as to provide a certain physical barrier to prevent the direct penetration of pathogenic microorganisms and particles.

[precautions]

1. Before use, check whether the package is in good condition and the package is damaged. It is forbidden to use it;

2. After the mask is wet, it should be replaced in time. It is recommended to wear it once every 4 hours;

3. Before entering the working area, the mask should be checked for tightness. If it is not suitable, please replace it;

4. It can be used for one-time health care in ordinary environment, not as special protection for surgical operation;

5. The product should be used as soon as possible after unsealing;

6. This product is disposable and should be treated according to the relevant regulations of medical waste after use.

[contraindications] it is forbidden for those allergic to materials.

[sample drawing of label and package identification]

It is sterilized by ethylene oxide; it is not allowed to be reused; it is forbidden to use the damaged package

[mode of supply] ethylene oxide gas is used for sterilization and sterile supply.

[instructions for use]

1. Open the product package, take out the mask, put one end of the nose clip upward and the side with the binding edge outward. Gently pull the ear strap to hang the mask on both ears. Avoid touching the inside of the mask with hands.

2. Gently press the nose clip to make it fit with the bridge of the nose, and then press and hold the nose clip. Pull the lower end of the mask down to the lower jaw to fully unfold the folded edge.

3. Arrange the wearing effect of the mask, so that the mask can cover the user's nose, mouth and mandible, and ensure the tightness of the mask.

[Registration Certificate No.] lxzz 20172640652

[product technical requirements No.] lxzz 20172640652

[production license No.] lsyjx production license No. 20140053

[registrant] Shandong Zhushi Pharmaceutical Group Co., Ltd

[registered address] Fanlou Road South, Shanxian Development Zone

[manufacturer] Shandong Zhushi Pharmaceutical Group Co., Ltd

[production address] No.6, Shande Road, food and Drug Industrial Park, Shanxian economic and Technological Development Zone, Shandong Province

[contact information] + 086 13256133668

[after sales service agency] Shandong Zhushi Pharmaceutical Group Co., Ltd

[storage conditions] the product shall be transported in accordance with the contract, and shall be covered to prevent rain and snow; the product shall be stored in a warehouse with room temperature, dry and well ventilated environment.

[service life] two years (obtained by accelerated aging).

made in China

医用儿童口罩英文.jpgEN TYPE 1医用非灭菌.jpgEN TYPE 1医用灭菌.jpgEN TYPE 2医用灭菌.jpgEN TYPE 2医用非灭菌.jpgEN TYPE IIR医用非灭菌.jpgEN TYPE IIR医用灭菌.jpg医用非灭菌口罩.jpg医用非灭菌口罩2.jpg

CE证书

202011120201112020111

FDA美国药监局备案

2020111

俄罗斯EAC豁免函

2020111

俄罗斯GOST自愿性证书

2020111

加拿大药监局备案MDEL证书

2020111

澳大利亚TGA认证

TGA.jpg

ISO9001证书

9001英文.jpg9001中文.jpg

ISO 13485证书

bsi13485英文.jpgbsi13485中文.jpg

SGS检验报告

sgs.jpg

TUV检验报告

tuv.jpg