Mask category

With the spread of new coronavirus pneumonia, masks and other medical protective equipment have become daily necessities, building a key line of defense for health and safety. Masks are divided into disposable medical masks, medical protective masks, PM2.5 protective masks, daily protective masks, etc.

application process

sign the application form

Send samples to testing institutions

Laboratory arrange sample test

After the test is passed, a test report is issued

Domestic sales

Test product

Disposable medical masks, medical surgical masks, daily protective masks.

Main test items

Appearance, color fastness to rubbing, formaldehyde content, pH value, decomposable aromatic amine carcinogenic dye, mask band and the connection between mask band and mask body, breaking capacity, breathing valve cover, coliform, Pseudomonas aeruginosa Staphylococcus aureus, hemolytic streptococci, total fungal colonies, total bacterial colonies, residual ethylene oxide, packaging and labeling.

standard test

YY / T 0969-2013 Executive standard for disposable medical masks GB / T 32610-2016 Technical specifications for daily protective masks

GB 19083-2010 "Technical Requirements for Medical Protective Masks"

YY 0469-2011 "Medical surgical masks"

YY / T 0969-2013 "Disposable Medical Masks"

GB / T 2626-2006 "Respiratory protective equipment self-priming filter anti-particulate respirator

GB / T 32610-2016 "Technical Specifications for Daily Protective Masks"

Export to Europe

Test product

Personal protective mask

Medical masks

Main test items

Performance testing, biological testing, expiratory resistance, exhalation valve leakage, filtration efficiency, etc.

Standard basis

Medical masks: EN14683 standard, affixed with the CE mark in accordance with the European Union Medical Device Directive 93/42 / EEC (MDD) or EU Medical Device Regulations EU2017 / 745 (MDR).

(1) Sterile medical masks: CE certification must be carried out by an authorized announcement agency.

(2) Non-sterile medical masks: enterprises only need to make CE self-conformity declaration, and do not need to pass the certification of the notified body. After preparing the relevant documents and test reports, you can complete the declaration of conformity yourself.

Personal protective mask: EN149 standard, which needs to meet the requirements of the EU Personal Protection Equipment Regulations EU2016 / 425 (PPE), and CE certification and certification will be issued by an authorized notified body.

Export to the United States

Test product

Personal protective mask

Medical masks

Main test items

Performance testing, biological testing, expiratory resistance, exhalation valve leakage, filtration efficiency, etc.

Standard basis

Personal protective masks: managed by the National Institute of Occupational Safety and Health (NIOSH).

Medical masks: managed by the US Food and Drug Administration (FDA)

Medical masks

Medical masks need to be registered by FDA, and companies apply directly to FDA's official website and submit relevant materials. There are also two alternative ways:

(1) N95 masks that have obtained NIOSH registration can be exempted from product registration (510K) when the product biological test, flame retardant test and blood penetration test are passed, and directly carry out FDA factory registration and medical device listing.

(2) If authorized by a manufacturer holding 510K, it can use its 510K approval number as its foundry for enterprise registration and device listing.

Personal protective mask

Protective masks need to be registered through NIOSH, and companies apply directly on the NIOSH official website.