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.
opro gum shield 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..
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
The global coronavirus outbreak has tested people, industries, governments and supply chains unlike any crisis since World War ,II,. ,Manufacturers, and ,suppliers, of personal ,protective, equipment (PPE) have been working overtime to increase production in response to unprecedented international demand.. ISEA’s companies and the workers who make PPE are working hand in hand with the ,medical, field ...
Our company has import-export operations right, national ,Class II medical device, registration certificate, CE certification and FDA certification which can independently and quickly complete the export of a large number of mask and ,protective, materials.Daily capacity: KN95 mask 100,000pcsDisposable mask 1,000,000pcsDisposable isolation gown 20,000pcsGoggles 5000pcsTechnology promotes progress ...
Medical protective clothing,, also known as ,medical protective, suit, disposable ,protective, coverall, or antivirus suit. ,Medical protective clothing, refers to the ,protective clothing, used by ,medical, personnel (doctors, nurses, public health personnel, cleaners, etc.) and people entering a specific health areas (such as patients, hospital visitors, persons entering the infected area, etc.).
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).
Generally, ,class II devices, must receive premarket clearance from FDA under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) before they can be legally marketed.10 FDA provides premarket clearance for ,devices, that are “substantially equivalent”—as the term is defined in section 513(i)(1)(A) of the FD&C Act (21 U.S.C. 360c(i)(1)(A))—to a predicate ,device,.
The Personal ,Protective, Equipment Regulation is a European one but it is one of the most stringent enforcement regulation relating to PPE in the world which is why the level of European PPE compliance is typically very high, especially relating to the Category 3 (Complex) which Arc Flash ,Protective Clothing, is in. This blog will explain the purpose, scope and timescale of the Personal ...
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 ...