mask

3m kn95 mask gb2626-2006 refers to the implementation standards that masks produced in China must comply with. This standard is now obsolete. The standard for masks currently implemented in China is gb2626-2019. Chinese standard name: 呼吸防护 自吸过滤式防颗粒物呼吸器; English standard name: Respiratory protection—Non-powered air-purifying particle respirator.

GB2626-2019,release date 2019-12-31; implementation date 2020-07-01.

GB2626-2019 specific information.

1 Scope

This standard specifies the classification and labeling, technical requirements, testing methods, and identification of self-priming filter anti-particulate respirators.
This standard applies to self-priming filter respirators that protect against particulate matter.
This standard does not apply to respirators for protection against harmful gases and vapors and does not apply to respirators for oxygen-deficient environments, underwater operations, escape and fire fighting.

2. Classification and marking

(1) Mask classification

According to the structure, the mask is divided into three types: disposable mask, replaceable half mask, and full mask.

(2) Classification of filter elements

Filter elements are divided into KN and KP according to their filtering performance. KN is only suitable for filtering non-oily particles, and KP is suitable for filtering oily and non-oily particles.

(3) Filter element level

3. The material and structure design of the respirator should meet the following requirements:

1) Materials should meet the following requirements:

(1) Materials in direct contact with the face should be harmless to the skin;
(2) The filter material should be harmless to the human body;
(3) The materials used should have sufficient strength, and there should be no damage or deformation that affects the use effect during normal use;
(4) There should be no obvious tenderness or tingling when wearing.

2) The structural design should meet the following requirements:

(1) It should not be easy to cause structural damage, and the design, composition, and installation of components should not pose any danger to the user;
(2) The design of the headband should be of elastic material or adjustable. It is easy to wear and remove. It should be able to firmly fix the face sheet on the face, and there should be no obvious compression or tenderness when wearing it. The replaceable half The headband design of the face mask and full face mask should be replaceable;
(3) If the same size number and the same style of the mask have different wearing methods, they should be tested as different products; the different wearing methods of the same style mask will affect the tightness of the mask.
(4) The vision should not be significantly affected;
(5) When wearing, the lenses of the full-face mask should not appear fogging and other conditions that affect vision;
(6) Respirators that use replaceable filter elements, inhalation valves, exhalation valves, and headbands should adopt a design that is easy to replace, and enable the wearer to check the airtightness of the mask and the face at any time and conveniently, and wear the air. Tightness check;
(7) The breathing tube should not restrict the movement of the head of the movement of the wearer, should not affect the tightness of the mask, and should not restrict or block airflow;
(8) The front of the exhalation valve should be protected. The exhalation valve protection device can be a special part, or it can be protected by other parts on the mask;
(9) The structure of the disposable mask should be able to ensure close contact with the face, and should not be deformed during normal use;
(10) The parts of the replaceable mask (except the filter element) should be washable.

4. The information provided by the manufacturer shall meet the following requirements:

1) Should be provided together with the smallest sales package.

2) There should be a description in Chinese.

3) The following information that users must know:

(1) The scope and limitation of application should include (but not limited to) the applicable particulate matter category (such as whether it contains oil). Designated protection of respirators
Factors, and/or other unsuitable application environments; if the product is not designed to be flame-retardant, there should be “This product is not suitable for open flames
“Workplace (such as welding, casting, etc.)” text description;
(2) For the replaceable filter element, explain the method of using it with a full face mask or a half-face mask. If it is a multiple filter material, it should be marked;
(3) Assembly method of the replaceable mask;
(4) Inspection methods before use;
(5) Wearing method and method of wearing air tightness inspection;
(6) For disposable masks, the method to judge its service life:
(7) For replaceable masks, provide advice on when to replace the mask or filter element;
(8) If applicable, maintenance methods (such as cleaning and disinfection methods);
(9) Storage method;
(10) The meaning of any symbols and icons used.

4) If the product claims that the filter element can be cleaned and/or disinfected and reused, the following information should be provided:

(1) Specific characteristics and/or scope of applicable particulate matter;
(2) The maximum number of times that can be cleaned and/or disinfected;
(3) A method to determine whether the filter element is still effective after cleaning and disinfection and when to replace it.

5) Provide warnings for problems that may be encountered during use, such as:

(1) Suitability to the wearer’s face;
(2) The hair under the tight frame will cause the mask to leak;
(3) Air quality (pollutants, hypoxia, etc.).

6) The information should be clear, and help descriptions such as explanations, part numbers, and labels can be added.

When comparing the N95 or N99 respirator mask, both are designed to protect workers from dust and airborne particles that can become airborne. The primary difference between the two is that the N95 respirator can only be used for particles of size one micron or smaller, while the N99 respirator mask can be used for particles up to one micron in size. So, what is the difference?

The difference between the materials used in N95 Mask and N99 Mask

The primary difference between the N95 particulate respirator mask and the N99 respirator mask is that the N95 respirator mask is a one-piece that is generally constructed of nylon with a Velcro closure and mask straps. This is a fairly simple design compared to an N99 particulate respirator mask, which can either be a one-piece mask, or a two-piece mask or a three-piece mask. The N95 particulate respirator mask also has a Velcro closure.

The N95 particulate respirator mask is constructed of a nylon polyester blend material that is relatively lightweight compared to the N99 particulate respirator mask which is made of a polyester powder coated nylon that is typically constructed of polyester and is heavy-duty. This powder coating of polyester allows for greater resistance to dust and airborne particles compared to a polyester composite material.

However, another important difference between the two is that the nylon polyester powder coated nylon material of the N95 respirator is more durable than the N99 particulate respirator mask. This means that if the nylon polyester powder coated nylon material is accidentally punctured during the workwear, the puncture does not allow for easy passage of air or dust particles into the wearer’s lungs.

On the other hand, the polyester composite material of the N95 particulate respirator mask can be easily punctured by particles of dust and air that can still pass through the polyester composite material into the wearer’s lungs. The nylon polyester powder coated nylon material can be easily punctured by a tiny air piece that can become airborne, or even a hairpin, which is a small metal object that can become airborne.

The difference between N95 Mask and N99 Mask to resist harmful substances

While the N95 is designed to protect against particles of dust and airborne particles, the N99 respirator masks can also protect against chemical vapors. The N99 respirator masks can be used for chemical vapors that are toxic to the eyes, nose, and throat such as benzene vapors, hydrogen sulfide, and chlorine vapors.

While both types of masks are designed to protect against dust and airborne particles, the N95 respirator mask can also protect against chemicals. However, the N95 particulate respirator mask is designed to be a one-piece mask, which is not as good for chemical protection as the N99 particulate respirator mask, because a small air piece can become airborne and go through a part of the nylon material on the mask during the wear. The N95 particulate respirator mask is designed to provide a more complete airtight fit and is less vulnerable to punctures.

The N95 respirator is also easier to use than the N99 respirator mask in that it is much easier to use, while still maintaining a one-piece design that prevents air leakage. When purchasing an N95 particulate respirator mask, it is important to keep in mind that the N95 respirator mask is more durable and less prone to punctures, so that it can be used for more hazardous situations such as chemical vapors.

The N95 respirator is also lighter, which makes it easier to carry and use for more hazardous situations. Both types of masks are designed to be lightweight and provide a more complete fit.

There are some situations in which the N95 particulate respirator mask is not the best choice of protection. If a chemical is involved and you are not a medical professional or are not knowledgeable about the proper use of a protective respirator, it is important to wear the appropriate one or to call for professional help.

It is also important to check the expiration date of a mask, and ensure that the replacement date is not past the expiration date. of a particular mask before wearing one.

N95 mask refers to the mask that passed the US NIOSH standard, but do you know how to pass it?

1. What is American NIOSH?

The National Institute of Occupational Safety and Health (NIOSH) works at the Centers for Disease Control and Prevention (CDC), a federal agency that specializes in generating new knowledge in the field of occupational safety and health and turning that knowledge into practice to improve workers.

Because personal protective equipment (PPE) plays an important role in keeping many workers in various industries safe during their duties, the National Personal Protection Technology Laboratory (NPPTL) was established as a department of NIOSH to prevent disease.

To accomplish this mission, NPPTL conducts scientific research, develops guidance and authoritative recommendations, disseminates information, and responds to the requirements of workplace health hazard assessment.

Under the authorization of the Occupational Safety and Health Act of 1970, the National Institute of Occupational Safety and Health (NIOSH) provides a test, approval, and certification program to ensure that the respirator used in the workplace meets the standards of 42 CFR Part 84.

Since 1994 NIOSH has maintained a searchable online version of the list of certified equipment.

NPPTL was established in 2001 at the request of Congress. The laboratory was created to meet the recognized need to improve personal protective equipment (PPE) and focus on personal protection technology (PPT).

2. N95 face mask US NIOSH certification requirements

According to the NIOSH guidelines, the enterprise needs to send samples to the NIOSH laboratory for testing, and submit technical information (including some quality system information) to the NIOSH document review. Only after the document review and test pass, NIOSH will issue the approval.

NIOSH classifies its certified anti-particulate masks into 9 categories, and specific tests are performed by NPPTL (National Personal Protective Technology Laboratory) laboratory under NIOSH.

The main test indicators include exhalation resistance test, exhalation valve leakage test, inhalation resistance test, and filtration efficiency test.

3. N95 face mask NIOSH certification standard:

National Institute of Occupational Safety and Health (NIOSH) New Standard for Dust Respiratory Protection 42CFR84

4. Introduction of FDA mask certification

N95 face mask

The N95 face mask that has been approved by NIOSH can be directly registered by the FDA.

According to updated data from the US Food and Drug Administration (FDA), as of April 13th, masks produced by 62 manufacturing plants in China have obtained FDA emergency use authorization (EUA), including such as KN95, ZK601 meets the Chinese national standards for a class of masks with particulate filtering efficiency.

Some industry sources said that obtaining the FDA’s emergency use authorization only represents that the mask is allowed to enter the United States, and American hospitals still recognize the masks that have obtained NIOSH certification.

Class II (special control) of surgical gowns and surgical masks. If the N95 surgical face mask or N95 filter face mask respirator is designed to prevent specific diseases or infections, or is marked or otherwise expressed as filtering surgical smoke or fumes, filtering a specific amount of viruses or bacteria, reducing the following diseases Quantity and/or killing viruses, bacteria or fungi, or affecting allergenicity, or including coating techniques not related to filtration (eg, reducing and/or killing microorganisms).

Surgical N95 respirators and N95 filter-mask respirators are not subject to the premarket notification procedures in Section E of Section 807 of this chapter, but subject to the following conditions of 878.9:

(i) It must be demonstrated that the components of the user’s contact with the device are biocompatible.

(ii) Analytical and non-clinical tests must:

(A) It is flammable and proved to be suitable for the intended use environment;

(B) Demonstrate the ability of the device to resist the penetration of fluids (such as blood and body fluids) at a rate consistent with the intended use of the device.

(iii) NIOSH is approved according to its regulations.

(2) Class I (conventional control) of surgical apparel other than surgical gowns and surgical masks.

5. U.S. entry requirements for masks and other anti-epidemic products:

Masks: The United States also manages medical masks and protective masks separately. Medical masks are managed by the US Food and Drug Administration (FDA), and personal protective masks are managed by the National Institute of Occupational Safety and Health (NIOSH).

Medical masks: Medical masks need to be registered with FDA, and companies apply directly to FDA and submit relevant materials.

There are 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 pass, 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 masks: protective masks need to be registered with NIOSH, and companies apply directly at NIOSH.

6. N95 NIOSH-approved masks

The N95 face mask is one of 9 anti-particulate masks certified by NIOSH (National Institute of Occupational Safety and Health).

“N” means not suitable for oily particles (oil fumes produced by cooking are oily particles, and the droplets generated by people talking or coughing are not oily);
“95” means that the filtration efficiency reaches 95% under the test conditions specified in the NIOSH standard. N95 is not a specific product name. As long as it conforms to the N95 standard and has passed the NIOSH review, it can be called the “N95 face mask”.

Masks are divided into 9 categories. The specific certification is operated by the NPPTL (National Personal Protective Technology Laboratory) laboratory under NIOSH.

According to the filtering characteristics of the middle filter of the mask, it is divided into the following three types:
N series: N stands for Not resistant to oil and can be used to protect non-oily suspended particles.
R series: R stands for Resistant to oil and can be used to protect non-oily and oily suspended particles.
P series: P stands for oil Proof and can be used to protect non-oily and oily suspended particles.
According to the low filtration efficiency of the filter material, the mask can be divided into the following three levels:
95 grade: indicates that the low filtration efficiency is 95%.
99 grade: indicates a low filtration efficiency of 99%.
100 grade: indicates a low filtration efficiency of 99.97%.

The appearance of COVID-19 makes face masks a daily necessity in our lives. For face masks, we often hear n95 face masks, kn95 face masks, and surgical face masks. There is an approved standard for n95 face mask in the United States, do you know?

What are N95 NIOSH-approved masks?

Particulate respirators are designed to help reduce the wearer’s exposure to airborne particulate hazards.
In the U.S., respirators are tested and certified by the U.S. National Institute of Occupational Safety and Health (NIOSH). NIOSH tests and certifies respirators based on their physical and performance characteristics, including filtration efficiency.

For example, N95-rated filtering facepiece respirators have a filtration efficiency of at least 95% against non-oily particles when tested using the NIOSH criteria. The particles used to test the filtration area in a size range that is considered the most penetrating.

Therefore, the test methods ensure that the filter media can filter particles with at least 95% efficiency.

FDA-Cleared Surgical Masks

Surgical masks are cleared for use as medical devices by the U.S. Food and Drug Administration (FDA), or equivalent agencies outside the U.S., and are designed to be worn by healthcare professionals during surgical procedures.

That clearance is based on data and proposed claims provided by the manufacturer to the FDA for review, in which the FDA evaluates and then “clears” those products that meet their requirements. Because surgical masks are meant for use during surgeries, a key performance requirement is a fluid resistance – the ability of masks to resist penetration by high-pressure streams of liquid, such as those that might result from a human artery being punctured during surgery.

Additional information about the differences between surgical masks and N95 respirators cab be found in the NIOSH infographic Understanding the Difference Between Surgical Masks and N95 Respirators.

Surgical N95 Respirators

Surgical N95 respirators are both approved by NIOSH as an N95 respirator and also cleared by the FDA as a surgical mask.

These products are frequently referred to as medical respirators, healthcare respirators, or surgical N95s. Comparing Standard N95s to Surgical N95sPutting this all together will help you differentiate between a standard NIOSH-approved N95 respirator and a surgical N95 respirator. While similar in appearance, the key difference is the fluid resistance and the resulting FDA clearance of surgical N95s.

N95 NIOSH-approved masks selection guide.

Protecting yourself from toxic fumes is important, and using the correct respirator is one of the best ways to protect yourself. NIOSH respirator masks are one of the most common choices when purchasing a respirator.

Protecting yourself from particulate matter and another hazardous chemical and biological material is important, but only a respirator that meets or exceeds the required standards can help you do this. Unfortunately, the masks that are currently available are not as effective as they could be. The various versions of the NIOSH respirator masks are not a good choice for all situations.

When buying an N95 Niosh approved mask, it is important to consider several factors. The mask should offer protection against the dust, smog, smoke, fumes, and various chemicals that the user may encounter in the workplace. It should also provide protection from the airborne particles that are often released from the operator’s body and face when the user moves around. The operator should feel safe and comfortable when wearing the mask.

The size of the respirator is important. It should fit properly. The person wearing the NIOSH respirator should feel like the mask fits them well. The airtight seal that the mask provides is another factor that needs to be considered.

When choosing a respirator, consider whether you will need multiple types of filters. There are specific NIOSH respirator masks that can filter out gases such as carbon dioxide, particulates, hydrogen sulfide, and sulfur dioxide. A respirator like this is particularly useful for protecting workers in certain hazardous industries.

If you are a heavy smoker or you will be exposed to second-hand smoke, you may want to consider using an air filtering respirator. The air filtration allows the lungs to receive oxygen, while the filter does its job. The benefits of using these types of respirators are important to consider.

When shopping for NIOSH approved masks, keep in mind that the manufacturer should be certified by the agency. That certification indicates that the manufacturer has met the requirements to produce a NIOSH approved respirator. It also indicates that the mask meets the required standards. To ensure that your NIOSH approved mask is an accurate match for your needs, it is important to look at the label.

Take the time to look at the labels for your N95 Niosh approved masks to ensure that the manufacturer meets the necessary requirements. You should be able to feel confident that you are wearing a NIOSH approved mask.

Are All N95 Masks NIOSH Approved?

The first thing you need to understand about N95 NIOSH-approved masks is that they are not NIOSH approved. That means that, while they may look like they are, they really aren’t.

NIH is the acronym for the National Institute for Occupational Safety and Health, which is an independent organization. But that’s not to say that every single N95 NIOSH-approved mask is certified by NIOSH. It’s not.

So how do you know that the mask you are buying is all N95 masks NIOSH approved? Simply put, you need to find out the certification number. Most masks are sold with a label that says “NAAMI.” If your mask does not have this label, then it’s not all N95 NIOSH approved.

Now let’s take a look at what N95 stands for. NIOSH stands for the National Institute for Occupational Safety and Health. It’s the foundation of all medical protection standards.

N95 is the final step in the certification process for NIOSH products. Basically, every company selling NIOSH-certified equipment will tell you that it is NIOSH-approved. That doesn’t mean that it actually is. The N95 certification process is so stringent that a product has to pass multiple tests in order to become certified.

Many people don’t even realize that the N95 rating on a certain pair of safety glasses or a certain type of respirator only gives a very rough indication of whether or not the product is NIOSH approved. You can have the best safety glass on the planet and still be rejected if it fails the final test, which is to test for particle particles. Even a pair of n95-rated glasses will not pass this test.

When you go to buy a pair of NIOSH-approved masks, you should make sure that they’re all approved by NIOSH. They should come with a label that reads “NAAMI.” Or, even better, ask for the certification number on the back of the mask and see if it’s there. You’ll know that you’ve found a pair of NIOSH-approved masks if the label is there, so take your time and double-check it.

If you get a NIOSH-approved mask and it does not come with a label saying “NAAMI,” return it and get a new one. This rule is in place for a good reason. People want to be sure that they are using a certified safety item.

N95 Niosh-Approved Masks are masks that have obtained the mandatory safety standards for respirators in the United States. This standard can only be passed by the EPA (a federal agency that has passed the N95 standard).

N95 Niosh-Approved Masks information introduction

N95 Niosh-Approved Masks said that under the testing conditions specified in the NIOSH standard, the filter material of the mask has a filtration efficiency of 95% for non-oily particles (such as dust, acid mist, paint mist, microorganisms, etc.).

The National Institute for Occupational Safety and Health (NIOSH) The National Institute of Occupational Safety and Health (NIOSH) is a federal agency dedicated to generating new knowledge in the field of occupational safety and health and converting that knowledge into practice to improve workers.

The N95 mask is one of the nine anti-particulate masks certified by NIOSH (National Institute of Occupational Safety and Health). “N” means not suitable for oily particles (the fume produced by cooking is oily particles, and the droplets produced by people talking or coughing are not oily); “95” means the filtration efficiency under the test conditions specified by the NIOSH standard Reach 95%. N95 is not a specific product name. As long as the products meet the N95 standard and pass the NIOSH review, they can be called “N95 masks”.

According to the filtering characteristics of the middle filter of the mask, it is divided into the following three types:

N series: N stands for Not resistant to oil, which can be used to protect non-oily suspended particles.
R series: R stands for Resistant to oil, which can be used to protect non-oily and oily suspended particles.
P series: P stands for oil Proof, which can be used to protect non-oily and oily suspended particles.

According to the lowest filtration efficiency of the filter material, masks can be divided into the following three levels:

Level 95: indicates that the minimum filtration efficiency is 95%.
Level 99: indicates that the minimum filtration efficiency is 99%.
Level 100: Indicates that the minimum filtration efficiency is 99.97%.

The combination is N100, N99, N95, R100, R99, R95, P100, P99, P95. There are 9 kinds in total.

N95 Niosh-Approved Masks application process

For manufacturers who apply for N95 for the first time, the application is divided into two stages:

The first stage. Submit a questionnaire (given by NPPTL) and photos (appearance of the company’s factory, product production line, etc.) for NPPTL evaluation. After the NPPTL evaluation is qualified, the manufacturer will be given an enterprise code and other relevant information, and the first stage is over. It will take about 3 weeks to one month to complete the first stage from the submission of the information.

second stage. After the first stage is over and the documents sent by NPPTL are received, detailed application materials are prepared. In addition to filling out the standard form, the company also needs to provide the following materials that meet the standard requirements: Pre-test data, Drawings, Assembly Matrix, Draft approval labels,QA manual,Process Quality Control Plan,Service Life Plan,User’s Instructions,Test samples and Hardware.

Pay the inspection fee in advance when submitting the information. If the submitted materials are unqualified, NPPTL will request rectification and provide it again. Everything went well, starting from the submission of information, the second phase will take about 3-4 months.

The manufacturer obtains N95 Niosh-Approved Masks. NIOSH will conduct random checks on the certified products sold by the manufacturer on the market every year to determine whether the company always meets the requirements of N95.

N95 Niosh-Approved Masks application notes

N95 certificates will only be issued to entities that can control product design, and only manufacturers and designers (contracted by others) can apply. Importers or any distributors cannot be the beneficiaries of the N95 certificate, which means that the N95 certificate will not be issued to them, whether it is a secondary conversion or they reapply (for the manufacturer’s product).

N95 certification is charged according to the model. The more models, the more expensive the cost. The specific classification is determined by NPPTL evaluation. That is to say, if the manufacturer provides a series model when applying, there are several small models below, NPPTL may require the manufacturer The model is divided and refined.

The above is the introduction about N95 Niosh-Approved Masks. If you want to know more about masks or buy masks, please contact us!