CE和FDA 双认证：博辉瑞进医用外科口罩（Medical Surgical Mask）中英文产品介绍

作者：本站编辑发布日期：2020-12-30

南德 TÜV CE证书编号：No.G2S 101395 0003 Rev.00

TÜV SÜD CE certificate：No.G2S 101395 0003 Rev.00

医疗器械注册证编号：京械注准20202140240

China Class II Medical Device Registration Certificate: 京械注准20202140240

产品分类：无菌/非无菌（Type: Sterile/Non-sterile）

佩戴方式：耳挂式/绑带式

Wearing Method: Ear-hang/Head-mounted

适用范围：适用于医务人员或相关人员的基础防护，以及在有创操作过程中阻止体液和喷溅物传播的防护。

Typical applications:Medical Surgical Mask is suitable for basic protection of medical staff and relavant personnel, as well as protection against the spread of body fluids and splashes during invasive procedures.

医用外科口罩

Medical Surgical Mask

耳挂式

绑带式

主要材质：采用经典SMS三层结构设计，外层阻水抗湿，内层透气吸水，中间层为25g/㎡熔喷布，为防止病原体微生物、体液、颗粒物等直接透过提供物理屏障。

Main material: It adopts the classic SMS three-layer structure design. The outer layer is water and moisture resistant, the inner layer is breathable and absorbance. The middle layer is 25g/㎡ melt-blown fabric, providing a phsical barrier to prevent the direct transmission of pathogenic microorganisms, body fluids, particles, etc..

过滤效率：可过滤平均直径3微米的细菌气溶胶，过滤效果95%以上。

Filtration efficiency: It can filter bacterial aerosols with an average diameter of 3 microns. Filtration efficiency is greater than 95%.

抗血液穿透：外层抗血液穿透压力超过120mmHg。

Fluid Pressure: Fluid pressure of the outer layer is greater than 120mmHg.