出口美国Export to the US

检测商品：本人防尘口罩、医用外科口罩                        

Test products: personal protective masks, medical masks

关键测试报告：功能测试、分子生物学检测、呼吸摩擦阻力、呼阀门泄漏、过滤效率等。

Main test items: performance test, biological test, exhalationresistance, exhalation valve leakage, filtration efficiency,etc.

规范根据 Standard basis

本人防尘口罩：由英国国家职业健康安全研究室（NIOSH）管理方法。

Personal protective masks: managed by the National Institute ofOccupational Safety and Health (NIOSH).

医用外科口罩：由英国食品类药监局（FDA）管理方法

Medical masks: managed by the US Food and Drug Administration(FDA)

医用外科口罩Medical masks

医用外科口罩需根据FDA申请注册，公司立即向FDA网申请办理并递交有关原材料。除此之外也有二种可选方式：

Medical masks need to be registered by FDA, and companies applydirectly to FDA's official website and submit relevant materials.There are also two alternative ways:

（1）早已得到NIOSH申请注册的N95口罩，在商品分子生物学检测、阻燃性检测和血夜透过产品测试的状况下，能够免除商品发售备案（510K），立即开展FDA加工厂申请注册和医疗机械字段名。

(1) N95 masks that have obtained NIOSH registration can beexempted from product registration (510K) when the productbiological test, flame retardant test and blood penetration testpass, and directly carry out FDA factory registration and medicaldevice listing.

（2）假如得到拥有510K的生产商的受权，能够做为其代工企业应用其510K准许号开展公司注册和器材字段名。

(2) If authorized by a manufacturer holding 510K, it can use its510K approval number as its foundry for enterprise registration anddevice listing.

本人防尘口罩Personal protective mask

防尘口罩需根据NIOSH申请注册，公司立即在NIOSH网申请办理。

Protective masks need to be registered through NIOSH, andcompanies apply directly on the NIOSH official website.