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.
Does Huai'an recruit workers
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
Protective clothing, should be worn in the following situations: ① When clinical ,medical, personnel come into contact with patients with infectious diseases ,of Class, A or ,Class, A infectious diseases. ②When exposed to patients with infectious diseases spread by air or droplets, they may be splashed by blood, body fluids, secretions and excreta.
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:
We are market leaders in developing innovative and easy to use solutions that allow you to tightly manage your requirements and budget. Our unique web based app - “MyWeb” – can save you over 30% on your workwear/PPE costs by giving you greater control on order quantity and budget.
Class, 1: ,Class, 2: ,Class, 3: ,Class, 4 : OSHA/EPA Level A PPE Equivalent NFPA 1991 (2005 ed.) ",Class, 1" PPE ensemble worn with NIOSH CBRN SCBA: OSHA/EPA Level B PPE Equivalent NFPA 1994 (2007 ed.) ",Class, 2" PPE ensemble worn with NIOSH CBRN SCBA OR NFPA 1971 (2007 ed.) "CBRN option" PPE ensemble worn with NIOSH CBRN SCBA OSHA/EPA Level C PPE Equivalent
The EU MDR 2017/745 has 4 main categories for ,Medical, Devices ,classification,:. ,Class, I; ,Class, IIa; ,Class, IIb; ,Class, III; This goes from the products with low risk (,Class, I) to the products with high risk (,Class, III). You can find this on the MDR 2017/745 (to be precise – Chapter V Section 1 Article 51). But if you want to be more specific, we can say that there are 3 sub-classes under ,class, I.
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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:
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.).
Test method for resistance of materials used in ,protective clothing, to penetration by blood-borne pathogens using Phi-X174 bacteriophage penetration as a test system (F1671/F1671M) As we are seeing with the the COVID-19 outbreak, viruses can be very resilient, and extensive precautions must be taken to protect ,medical, professionals and patients from potential transmission in a hospital setting.
If a product is designed to be PPE rather than a ,medical, device, the product has to comply with the corresponding directive 89/686/EEC (,protective clothing,) and standard “EN 14126 Performance requirements and tests methods for ,protective clothing, against infective agents.”
Article 4 According to degree of risk (from low to high), the classifications of ,medical, devices are divided into ,class, I, ,class II, and ,class, III in due order. The risk degree of a ,medical, device shall be determined comprehensively according to the intended purpose, structural characteristics, pattern of use, status of use as well as whether the device is body contacting.