产品详情
Disposable Surgical face mask,3Ply with ties,EN 14683:2019 Type IIR 
品牌: ZHUSHI
产品详情

3Ply with ties

Size:17.5*9.5cm

Disposable Surgical face mask

Non-Sterile

EN 14683:2019 Type IIR

WhatsApp:+86 13256133668

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

The company has passed ISO 13485:2016 and ISO 9001:2015 certification

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    我集团日产600万只一次性医用外科口罩,口罩符合国标/欧标/美标等全世界常用标准。欧洲标准EN14683:2019 Type IIR口罩我们有货,有资质。产品取得BSI证书,真正的CE证书,FDA备案,取得俄罗斯EAC豁免函,加拿大药监局MDEL备案,澳大利亚TGA认证,另外取得ISO13485,ISO9001证书,并且有SGS/TUV检验报告,进出口商会医疗器械自营销售证书等。产品行销海内外,长期出口世界各地。

Our group has a daily output of 6 million disposable surgical masks, which meet the national standard / European standard / American Standard and other commonly used standards all over the world. We have the European standard en14683: 2019 type IIR mask, and we have the qualification. The products have obtained BSI certificate, real CE certificate, FDA record, EAC exemption letter from Russia, mdel record of Canadian drug administration, TGA certification of Australia, ISO 13485 and ISO9001 certificate, SGS / TUV inspection report, self-service   sales   certificate   of   medical   devices   of   import   and   Export   Chamber   of Commerce, etc. The products are sold at home and abroad and exported to all over the world for a long time.

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[product name] disposable Surgical mask

3Ply with ties

Size:17.5*9.5cm

Non-Sterile

EN 14683:2019 Type IIR

[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

[structure composition] This product is made up of three materials, non-woven fabric,   nose strip and rubber band.   The mask body is divided into three layers: inner, middle and outer, the inner layer is ordinary non-woven fabric,   the middle layer is ultra-fine polypropylene fiber melt jet cloth, and the outer layer is non-woven.   The mask belt is made of rubber band, which is made of non-woven cloth with rubber band;   the material of nose strip is metal strip,and it is made of plastic wrapped with fine galvanized iron wire. According to whether the sterile supply is divided into sterile type and non sterile type, it is used once.

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[performance index] the breaking strength of each mask belt and the junction point of the mask body shall not be less than 10N; the filtration efficiency of the mask shall not be less than 95%; the ventilation resistance of gas exchange on both sides of the mask shall not be greater than 49pa/cm; the total number of bacteria colonies of non sterile mask shall be no more than 100cfu/g, and the large intestinal flora, Pseudomonas aeruginosa, Staphylococcus aureus, hemolytic streptococcus and fungi shall not be detected.

[scope of application] for clinical personnel to wear during non-invasive operation,   covering the mouth,   nose and jaw of users,and provide a certain physical barrier for preventing the direct transmission of pathogens, microorganisms and particles.

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[precautions]

1. before use, check whether the package is intact, the package is damaged and it is forbidden to use;

2. after the mask is wet, it should be replaced in time, and it is recommended to wear it once for 4 hours;

3. before wearing masks into the work area, tightness inspection shall be conducted. If not, please replace them;

4. it is used for disposable health care in general environment, and it is not used as special protection for surgical operation;

5. the product shall be used as soon as possible after opening;

6. the product is disposable, and it shall be treated according to the relevant provisions of medical waste after use;

7. non sterile mask is applicable to the non protective isolation requirements medical environment and non special purification requirements medical environment, and it is not suitable for sterile operation.

Contraindications: 1. forbidden for people with material allergy;

2. it is not allowed to be used twice;

3. it is forbidden to use if the package is damaged

[supply method] non sterile supply

[instructions for use]

1. open the product packaging, take out the mask, put one end of nose clip upward, one side facing outward with the edge of the package, and gently pull the ear strap to hang the mask on both ears, so that the hand should not contact the inside of the mask.

2. press the nose clamp gently to make it fit with the nose beam, and then press and hold the nose clamp. Pull the lower end of the mask down to the jaw so that the folded edge is fully extended.

3. arrange the wearing effect of the mask so that the mask can cover the nose, mouth and jaw of the user and ensure the tightness of the mask.



CE证书

FDA美国药监局备案

俄罗斯EAC豁免函

俄罗斯GOST自愿性证书

加拿大药监局备案MDEL证书

澳大利亚TGA认证

ISO9001证书


ISO 13485证书

SGS检验报告

TUV检验报告

202132




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