CE Documentation Review

No. 3J200321.SHLUO46

Holder:Shijiazhuang Haiyuan Labor Security Supplies Co., Ltd. South of Yinglixin Village, Macun Town, Yuanshi County, Shijiazhuang, Hebei Province (Equipment Manufacturing Base)

Review goal:Verification of the presence of Technical Documentation compatible with the Medica Devices Directive 93/42/EEC Annex VIl

Product:Disposable medical isolation gown (Not Sterile)

Model(s):60g coated sms non-woven fabric,S160 / M165 / L170 / XL175/2XL180/3XL185/4XL190

Classification:Class I (Not Sterile) (accordingly to the Manufacturer's declaration)

Review output:This document has been issued on a voluntary basis and upon request of the manufacturer. It is our opinion that the Technical Documentation shared withus by the manufacturer is compatible with the European Standard for Medical Devices.

The manufacturer is responsible for the CE Marking process, and not exempted to carry out all necessary compliance activities. This document has been issued on the basis of the regulation on ECM Voluntary Mark for the certification of products. RG01_ECM rev.3 available at:www.entecerma.it