logo
chat

Chat
Online

chat

Inquiry

chat

Email

chat
Home > black cool face mask

black cool face mask

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.

Why choose us

Solutions to meet different needs

Solutions to meet different needs

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.

Highly specialized team and products

Highly specialized team and products

Professional team work and production line which can make nice quality in short time.

We trade with an open mind

We trade with an open mind

We abide by the privacy policy and human rights, follow the business order, do our utmost to provide you with a fair and secure trading environment, and look forward to your customers coming to cooperate with us, openly mind and trade with customers, promote common development, and work together for a win-win situation.

24 / 7 guaranteed service

24 / 7 guaranteed service

The professional team provides 24 * 7 after-sales service for you, which can help you solve any problems

Certificate of honor


CONTACT USCustomer satisfaction is our first goal!

Consultation hotline:0086-15900663312

Address:No. 3888, Hutai Road, Baoshan District, Shanghai, China

black cool face mask

Respiratory Protection and Surgical Face Mask CE Certificate

Respiratory Protection and Surgical Face Mask CE Certificate

Evaluation of ,surgical masks, in Europe In Europe, ,surgical masks, must wear a ,CE mark, and comply with the requirements defined in EN 14683: Medical face ,masks, - Requirements and test methods. The standard defines ,surgical masks, as follows: medical devices covering the mouth, nose, and chin provide a barrier that limits the passage of an infective agent between hospital staff and the patient.

Get Price
CE Marking & COVID-19 - Update | CE Marking Association

CE Marking & COVID-19 - Update | CE Marking Association

UPDATE: We have now published our plan and risk assessment for Phase 1 of reopening our office and permanent reopening of our laboratory; please see here for details and here for our Risk Assessment . Subsequent to our previous post regarding the ,CE Marking, of ,surgical masks, used to prevent the spread of the COVID-19 virus, the UK Regulatory Authorities have moved quickly to assist ...

Get Price
Italy: Medical Masks Without CE Marking | Insight | Baker ...

Italy: Medical Masks Without CE Marking | Insight | Baker ...

The National Health Institute and Confindustria Dispositivi Medici (the Italian Association of Medtech Companies) jointly developed a technical datasheet identifying essential requirements for the placing on the market of ,surgical masks, for medical use not bearing the ,CE marking, pursuant to Article 15 of Decree Law No. 18 of March 17, 2020, so-called Decree "Cura Italia".

Get Price
Medical devices: conformity assessment and the CE mark ...

Medical devices: conformity assessment and the CE mark ...

A ,CE mark, is a logo that is placed on medical devices to show they conform to the requirements in the directives. It shows that the device is fit for its intended purpose stated and meets ...

Get Price
Conditions for delivery and release of surgical face masks

Conditions for delivery and release of surgical face masks

Sterile ,surgical, face ,masks, need to bear a ,CE marking, followed by a 4 -digit code. See also figure below. These 4 digits identify the notified body that assessed the elements for securing and maintaining the sterile conditions. The notified body issues a ,CE, certificate for this purpose.

Get Price
Classification Of Medical Devices And Their Routes To CE ...

Classification Of Medical Devices And Their Routes To CE ...

There are four possible routes to ,CE mark, your product, split into two groups given the product’s type, i.e., if it’s sterile or not. Table 2. ,CE marking, routes of Class IIa Medical Devices. Class IIb Medical Devices. Here, we can include medical devices such as long-term corrective contact lenses, ,surgical, lasers, defibrillators, and others.

Get Price
Evaluation of medical face masks | Centexbel - VKC

Evaluation of medical face masks | Centexbel - VKC

In Europe, ,surgical masks, must wear a ,CE,-,mark, and comply with the requirements defined in EN 14683: Medical face ,masks, - Requirements and test methods. The standard defines ,surgical masks, as: medical devices, covering the mouth, nose and chin ensuring a barrier that limits the transition of an infectious agent between the hospital staff and the patient.

Get Price
Mask CE Certificate - CE İşareti | CE Belgesi | CE ...

Mask CE Certificate - CE İşareti | CE Belgesi | CE ...

Surgical masks, are considered first-class medical equipment, and manufacturers must conduct risk analyzes and additional tests in accordance with the European Medical Device Directive 2017/745. After these processes are passed, the manufacturer can put the ,CE mark, on the ,masks,. What is Bacterial Filtration Efficiency Test?

Get Price
Comparison of Mask Standards Ratings and Filtration ...

Comparison of Mask Standards Ratings and Filtration ...

Single use ,masks, (normally one layer, very thin) are typically only effective at capturing larger dust particles, but can do so fairly well. ,Surgical mask, standards have higher requirements for capturing virus-sized (0.1 micron) particles, however they vary by region. Pollution ,masks, (respirators) typically capture >90% of virus-sized particles.

Get Price
CE Marking & COVID-19 - Update | CE Marking Association

CE Marking & COVID-19 - Update | CE Marking Association

28/3/2020, · UPDATE: We have now published our plan and risk assessment for Phase 1 of reopening our office and permanent reopening of our laboratory; please see here for details and here for our Risk Assessment . Subsequent to our previous post regarding the ,CE Marking, of ,surgical masks, used to prevent the spread of the COVID-19 virus, the UK Regulatory Authorities have moved quickly to assist ...

Get Price
CE Certification - Class I Medical Device CE Marking

CE Certification - Class I Medical Device CE Marking

But majority of the manufactures still depend on a third party Certification to get a reputed ,CE, Certificate. [b] Class I Sterile Devices. Class 1 Sterile Device ,CE Marking, process can be completed only by complying with MDD requirements and Harmonized Standards, followed by submitting Technical File to Notified Body and Site Audit.

Get Price
CE Marking IVD

CE Marking IVD

CE marking, PPE, ,ce mark, PPE, ... If the answer is Yes your product is a medical device or personal protective equipment depending on the intended use; a ,surgical mask, is a medical device; a ,mask, to protect the wearer against microbial and viral infections is personal protective equipment.

Get Price
Face Mask Regulations and Standards in the EU: An Overview

Face Mask Regulations and Standards in the EU: An Overview

2/4/2020, · Do Type IIR ,masks, need a ,CE mark, assuming they have passed all tests? EN says the requirements on the packaging are ‚only‘: Both the Medical Device Directive (93/42 / EEC) and the Medical Device Regulation (EU) 2017/745 specify the information that should appear on the packaging in which the medical face ,mask, is supplied.

Get Price
Surgical Face Mask CE Marking | 🥇I3CGlobal

Surgical Face Mask CE Marking | 🥇I3CGlobal

Non Sterile ,Surgical, Face ,Mask CE Marking, and EU Registration is mandatory for marketing the medical device in the European region. The present European Medical Device Directive (MDD) has to be followed with regard to Class 1 medical devices.. Since it falls under Class 1, Non-Sterile ,Surgical Mask, can be self Certified as per MDD 93/42/EEC.

Get Price
Mask CE Certificate - CE İşareti | CE Belgesi | CE ...

Mask CE Certificate - CE İşareti | CE Belgesi | CE ...

Surgical masks, are considered first-class medical equipment, and manufacturers must conduct risk analyzes and additional tests in accordance with the European Medical Device Directive 2017/745. After these processes are passed, the manufacturer can put the ,CE mark, on the ,masks,. What is Bacterial Filtration Efficiency Test?

Get Price
Surgical Mask CE Certificate - CE İşareti | CE Belgesi

Surgical Mask CE Certificate - CE İşareti | CE Belgesi

Surgical masks, are also included in this group. The basic standard that must be complied with in order to put the ,CE mark, on the ,surgical masks, is the TS EN 149 standard (Respiratory protective devices - Half ,masks, with filters for protection against particles - Properties, experiments and ,marking, standard).

Get Price
CE marking of medical face masks - Force Technology

CE marking of medical face masks - Force Technology

Is ,CE marking, a requirement for medical face ,masks,? Yes. According to the Executive Order on Medical Devices, it is required that medical face ,masks, are ,CE, marked when they are advertised and sold within the European market and thus also in Denmark. The ,CE marking, is the manufacturer’s guarantee that the ,mask, complies with current EU legislation.

Get Price