Shanghai Sunland Industrial Co., Ltd is the top manufacturer of Personal Protect Equipment in China, with 20 years’experience. We are the Chinese government appointed manufacturer for government power,personal protection equipment , medical instruments,construction industry, etc. All the products get the CE, ANSI and related Industry Certificates. All our safety helmets use the top-quality raw material without any recycling material.
silicone gas filter mask
We provide exclusive customization of the products logo, using advanced printing technology and technology, not suitable for fading, solid and firm, scratch-proof and anti-smashing, and suitable for various scenes such as construction, mining, warehouse, inspection, etc. Our goal is to satisfy your needs. Demand, do your best.
Professional team work and production line which can make nice quality in short time.
Address：No. 3888, Hutai Road, Baoshan District, Shanghai, China
Disposable ,Medical Protective Clothing, (sterile or non sterile) ,Class, I CE Certified, Related Standard EN 13688 FDA Certified, Related Standard ASTM F1671-97A ,Class II, CE Certified, Related Standard EN 14126 FDA Certified, Related Standard ASTM F1671-97A
(5) Masks made of other materials, such as new bio-,protective, filtering materials. 1.1.4 ,Classification, by Application (1) ,Medical, masks: divided into three categories in China, a) General ,medical, masks, b) ,Medical, surgical masks, and. c) ,Medical protective, masks.
Protective medical, masks are generally managed as a ,Class II medical, device. CIRS Group summarizes the technical requirements for the registration and declaration process of mask products based on ,medical, device regulations and ,medical, mask registration requirements.
For ,protective clothing, which passes EN 14126:2003, wording “-B” will be added behind “TYPE” ,classification,, namely “TYPE 3-B”, “TYPE 4-B” and “TYPE 5-B”. A standard is reviewed every 5 years. EN 14126:2003 includes 5 test methods to determine the protection ,class, …
Manufacturers ,of Class II medical, devices must also register, list, and pay a fee. They are also required to manufacture their devices in compliance with the QSR. ,Class II, devices generally require premarket clearance; however, the FDA has exempted certain ,Class II, face masks (N95 respirators, product code MSH) from premarket authorization under the following conditions:
2016/42 European Regulation (EU) 2016/425 covers the process for CE Marking Personal ,Protective, Equipment (PPE) described as any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards. The following are also included in the scope of the Regulation requiring a CE mark to be affixed:
The standard classifies the ,protective, gown penetration resistance to synthetic fluids into 6 levels, with 6 being the highest. Both ISO 16603 Level 2 (,CLASS, 2) and the Chinese National Standard are 1.75kPa. European standard ,protective clothing, must have EN14126, and at least reach TYPE4, in order to meet the national standard.
Category ,II,: ,Protective clothing, that protects the wearer against hazards; PPE that does not fall into category 1 or category 3 Category III: ,Protective clothing, that protects the wearer ... ,Class, in acc. EN 14327 ,Class, in acc. EN 14326 ,Class, in acc. EN 14325 Acetone 67-64-1 6 of 6 1 of 6 1 of 6