服务热线:13256133668
产品详情
医用防护服出口欧洲,disposable medical protective suit 
产品详情

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disposable protective suit medical use

[product name] disposable protective suit medical use

[model and specification] conjoined 160, 165, 170, 175, 180, 185

[manufacturer] Shandong Zhushi Pharmaceutical Group Co., Ltd

[registered address] Fanlou Road South, Shanxian economic and Technological Development Zone

[production address] south of Fanlou Road, Shanxian economic and Technological Development Zone

[date of manufacture]

[term of validity] three years

[contact information] 132 5613 3668

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

[executive standard No.] GB 19082-2009

[Registration Certificate No.] lxzz 20202140108

[structure composition] it is made of non-woven fabric by sewing and bonding.

[scope of application] it is used for blocking and protecting the blood, body fluid and secretion of patients with potential infection that are exposed to clinical medical staff during work.

[performance index]

1. Liquid barrier function: a) hydrostatic pressure of key parts shall not be lower than 1.67kpa (17cmh20). b) The moisture permeability of the material should not be less than 2500g / (M2 · d).

2. The penetration resistance of protective clothing to synthetic blood should not be less than 1.75kpa.

3. The water level on the outer surface shall not be lower than grade 3.

4. Elongation at break: the elongation at break of materials in key parts shall not be less than 15%.

5. The filtration efficiency of materials at key parts and joints for non oily particles shall not be less than 70%.

6. Antistatic property: the charged capacity shall not be greater than 0.6 μ C / piece.

7. Electrostatic attenuation performance: the electrostatic decay time shall not exceed 0.5s.

8. Ethylene oxide residue: no more than 10 μ g / g.

[precautions, warnings and suggestive instructions]

1. This product is sterile and disposable, with a validity period of three years;

2. This product is only for one-time use.   It should be used immediately after opening the package.   The use time should not exceed 24 hours. It should be incinerated after use;

3. Do not use if damaged or improper zipper or suture is found before wearing;

4. Protective clothing should avoid long-term contact with chemicals.

5. This product has no flame retardancy.

[usage] unfold the protective clothing, open the zipper, stretch into the legs from the opening of the zipper in turn, then wear the coat, stretch out the hand from the sleeve, wear the headgear, and pull the zipper from the front of the chest.

[sample drawing of label and package label] it is forbidden to use the damaged package. It is only for one-time use after being sterilized by ethylene oxide. Keep dry

[storage conditions and methods] the product should be stored in a clean environment without corrosive gas, dry, free from sunlight, and kept away from open fire.

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  我们公司日产20万套防护服,防护服有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认证产品行销海内外。符合欧洲标准EN14126,资质齐全,国家药监局备案,二类医疗器械,环氧乙烷灭菌。产品取得BSI证书,真正的CE证书,另外取得ISO13485,ISO9001证书,并且有TUV检验报告,进出口商会医疗器械自营销售证书等。

Our company has a daily output of 200000 sets of protective clothing. The protective clothing has CE certificate and FDA filing. It has obtained the EAC exemption letter from Russia, mdel record of Canadian drug administration, and TGA certification of Australia. The products are sold at home and abroad. It conforms to the European standard en14126, with complete qualification, filed by the State Food and drug administration, class II medical devices, and ethylene oxide sterilization. The products have obtained BSI certificate, real CE certificate, ISO13485 certificate, ISO9001 certificate, TUV inspection report, medical device self-service sales certificate of chamber of Commerce of import and export, etc.

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

TUV检验报告

进出口商会医疗器械自营销售证明

Shandong Zhushi Pharmaceutical Group Co., Ltd. established in 2003, and located in shanxian, Heze city, Shandong province, China. With a registered capital of 500 million yuan, more than 5000 registered employees, and the company has 2 modern science and health industrial parks, the total area about 380000m², annual output value of 3 billion yuan.

The company adopted almost demanding standards to create perfect products and has passed the 13485 certification, CE certification and FDA certification issued by the British authority. Establish the quality management system according to ISO9001 and ISO13485 standards, strictly regulate the production process, use CP, MSA, 5S and other management concepts to strengthen the control of product quality, at the same time have the import and export license, electronic port and entry and exit inspection and quarantine application procedures for enterprises.

After more than ten years of vigorous development, the company has formed a collection of production and sales of medical devices, disinfection and sanitary products, polymers, cosmetics, health foods, research and development of biological reagents, corporate management consulting and training, real estate economy, pharmaceutical transportation and pharmaceutical printing etc. A diversified modern Chinese medicine industry cluster with a core of the pharmaceutical industry.

We are sincerely looking forward to cooperating with more overseas customer based on mutual benefits and long term potential.

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