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医用防护口罩(非无菌型)

医用防护口罩(非无菌型)

医用防护口罩
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医用防护口罩(非无菌型)产品说明书

 

【产品名称】 医用防护口罩(非无菌型)

【型号/规格】型号:B1(折叠型耳挂式);规格:XL-c(18cm×11cm);L-c(16cm×10cm);M-c(14cm×9cm);S-c(12cm×8cm);XS-c(10cm×7cm)。具体产品的型号/规格详见标签。

【适用范围】适用于医护人员和相关工作人员对经空气传播的呼吸道传染病的防护。不能用于隔离重症监护病区(房)等有严格微生物指标控制要求的场所。

结构及组成】由口罩体、鼻夹、口罩带组成。口罩体内外层为无纺布,中间层为熔喷布。产品非无菌供应。

【注册人/生产企业名称】长沙邦创生物科技有限公司

【生产地址】浏阳经济技术开发区康万路188号汉元孵化园A栋二楼

【注册人/生产企业住所】浏阳经济技术开发区康万路188号汉元孵化园A栋二楼

【注册人/生产企业联系方式】400-666-5548

【售后服务单位】长沙邦创生物科技有限公司

【生产许可证编号】湘食药监械生产许20150038号

【注册证编号/产品技术要求编号】湘械注准20202140393

【产品性能】产品符合GB 19083-2010的要求,非油性颗粒过滤效率≥95%

【禁忌症】暂无明确研究资料

【注意事项、警示以及提示的内容】

1. 本品为一次性使用产品,严禁重复使用,用后销毁。

2. 本品为一次性使用产品,连续使用时均应及时更换,单次佩带时间不应超过4小时。

3. 心肺功能异常者谨慎使用。

使用说明

1. 口罩取出后,将有鼻夹定型件的部分朝上,使口罩覆盖鼻、口部位。

2. 各种形状口罩展开后均为凹面朝里,凸面朝外;

3. 戴好耳带,捏紧鼻夹,使其紧贴鼻梁和面部。

贮存方法】应保证包装完好,避免潮湿和高温,在室内无腐蚀性气体、通风良好的自然条件下贮存。

【生产批号】详见标签

【生产日期】详见标签

【有效期限】一年

【标签所用的图形、符号、缩写等内容的解释】详见标签。


 

【说明书修订日期】本说明书修订日期为2020年2月1日。

                 

                                                             Manual for Protective Face Mask for Medical usenon-sterile


Product NameProtective Face Mask for Medical use(non-sterile

Type/SpecificationsB1 (Folded ear-loop style). Specifications:XL-c18cm×11cmL-c16cm×10cm);M-c14cm×9cm);S-c12cm×8cm);XS-c10cm×7cm. Please refer to the label for details.

Scope of ApplicationApplicable to the protection of medical care workers and related workers (adults) to against airborne respiratory infectious diseases.It should not be used for isolation of critical care areas (rooms ) and other places with strict control of microbial indicators .

CompositionIt consists of mask body, nose clip and ear rope. The inner and outer layers of the mask are non-woven fabric, and the middle layer is melt-blown fabric. The product is supplied non-sterile

Registrant /ManufacturerChangsha Biostrong Technology Co., Ltd.

Manufacturing AddressFloor 2,Building A,Hanyuan Incubator Garden,188Kangwan Rd,

Liuyang Economic and Technological Development Zone,Changsha,Hunan Province

Registrant /Company AddressFloor 2,Building A,Hanyuan Incubator Garden,188Kangwan Rd,

Liuyang Economic and Technological Development Zone,Changsha,Hunan Province

Contact Number400-666-5548

After-sales Service ProviderChangsha Biostrong Technology Co., Ltd.

Manufacturing License(s):Hunan CFDA Production Permit No. 20150038

Registration Certificate No./Technical Requirement No.HNMPA Certified.20202140393

PerformanceThe product conforms to GB 19083-2010, and the filtration efficiency of non-oily particles is ≥95%.

ContraindicationNo data available.

Warning

1.This product is meant for one-time use, not for repeated use. Destroy it after used

2.Please to replace it timely ,Consistent wearing time should not exceed 4 hours.

3. Use with caution for those weak in heart and lungs.

Direction for Use

1.Take out the mask and upward the nose bridge clip make sure the mask complete cover the nose, mouth and jaw

2.The concave side should face inwards, and the convex side outwards.

3.Put the strap behind the ears and tighten the clip on the nose to keep the mask fit on the face.

StorageThe packaging should remain intact, kept away from humid and hot places, and stored in airy place without corrosive gases. 

Batch NoRefer to label for details

Manufacturing DateRefer to label for details

Validity periodOne year.

Interpretation of Graphics,Symbols,Abbreviations,etc.used in labelsRefer to the pictures below for details

Revision DateThe manual is updated on February 1, 2020.

400-666-5548
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