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.
face mask chair
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..
The professional team provides 24 * 7 after-sales service for you, which can help you solve any problems
Pandemic ,Protection, Kits. Complete ,protection, kits for people working in a biohazard areas. For example during epidemics / pandemics such as Ebola, bird flu, Mexico flu. These kits comply with the advice of the German Robert Koch Institute (RKI) for ,protective clothing, against infection of types 1 or 2. More
30/3/2020, · ,Medical devices, and equipment are regulated in the United States and the European Union. ... their products are manufactured according to the EN Standard 149 for respiratory ,protective devices,, ... surgical masks are classified as ,Class II medical devices, by the FDA and are regulated under 21 CFR Section 878.4040.
Personal ,protective, equipment sold for ,medical, purposes are classified as ,medical devices, in Canada. Under the ,Medical Devices, Regulations, ,medical, masks, N95 respirators, ,medical, gowns, face shields and ,medical, goggles are ,Class, I ,medical devices,. ,Medical, gloves are ,Class II medical devices,. On this page . Expedited access
In accordance with the ,Medical Devices, Regulation (EU) 2017/745, a ,manufacturer, is defined as: “A natural or legal person who manufactures or fully refurbishes a ,device, or has a ,device, designed, manufactured or fully refurbished, and markets that ,device, under its name or trademark.”
MID ,MEDICAL, is a global ,medical, trade company that integrates I, ,II, and III medcial ,devices,. The outbreak of the COVID-19 confronts us with a major challenge, as it does for all ,manufacturers of protective, equipment and ,medical devices,. The demand for PPE has rise exorbitantly.
Class II,: ,Devices, for which general controls, by themselves, are insufficient to provide reasonable assurance of the safety and effectiveness of the ,device,, and for which there is sufficient information to establish special controls to provide such assurance. •A 510(k) is a premarket submission made to FDA to demonstrate that the new ,device, to be marketed is “substantially equivalent” to ...
Manufacturers, of all ,medical devices, ... ISO 22609:2004 ,Clothing, for ,protection, against infectious agents - ,Medical, face masks ... PPE is generally classes as a ,Class, I ,medical device,. If your product is supplied in a sterile state, it will be classed as ,Class, Is (sterile).
1/1/2014, · ,Protective medical clothing, is an important segment of ,medical, products with ... as ,Class II Medical devices,. 10 The USA Occupational Safety and Health Administration (OSHA), 11 the Centers for ... most ,manufacturers, are expected to claim compliance to the standard. In this standard, barrier performance attributes include ...