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医用防护口罩(无菌型)

医用防护口罩(无菌型)

无菌型
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4)医用防护口罩(无菌型)产品说明书

 

【产品名称】 医用防护口罩(无菌型)

【型号/规格】型号:A1(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(成人)对经空气传播的呼吸道传染病的防护。

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。经环氧乙烷灭菌,产品无菌供应。

【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20202140392

【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. 灭菌产品有效期为一年,请确认有效期后使用,包装破损严禁使用。

2. 本品为一次性使用产品,严禁重复使用,用后销毁。

3. 灭菌产品开封后应立即使用;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。

4. 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 usesterile


【Product Name】Protective Face Mask for Medical use(sterile)

【Type/Specifications】:Type A1(Folded ear-loop style).Specifications: XL-c(18cm×11cm);

L-c(16cm×10cm);M-c(14cm×9cm);S-c(12cm×8cm);XS-c(10cm×7cm). Please refer to the label for details.

【Scope of Application】Applicable to the protection of medical care workers and related workers (adults) to against airborne respiratory infectious diseases.

【Composition】It 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. ethylene oxide sterilization

The product is supplied in sterile state.

【Registrant/Manufacturer】Changsha Biostrong Technology Co., Ltd.

【Manufacturing Address】Floor 2,Building A,Hanyuan Incubator Garden,188 Kangwan Rd,

Liuyang Economic and Technological Development Zone,Changsha,Hunan Province

【Registrant/Manufacturer Address】Floor 2,Building A,Hanyuan Incubator Garden,188 Kangwan Rd,

Liuyang Economic and Technological Development Zone,Changsha,Hunan Province

【Contact Number】400-666-5548

【After-sales Service Provider】Changsha Biostrong Technology Co., Ltd.

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

【Registration Certificate No./Technical Requirement No.】HNMPA Certified.20202140392

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

【Contraindication】No data available.

【Warning】

1.This product is disposable, not for repeated use. Please check date and packing before use. It is strictly prohibited to use when the package is damaged

2.Repeated use is not allowed. Destroy it after used.

3.Use immediately after opened the packing. Continuous use should not exceed four hours.

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

【Direction for Use】

1.Take out the mask and cover the nose, mouth and jaw with the clip sitting on nose bridge.

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 the face.

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

【Batch No】Refer to label for details

【Manufacturing Date】Refer to label for details

【Validity Period】One year.

【Interpretation of Graphics, Symbols, Abbreviations, etc. used in labels】Refer to the pictures below for details

【Revision Date】The manual is updated on February 1, 2020.

400-666-5548
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