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KN95/FFP2 NR Filtering Facepiece Respirator, Non-NIOSH Approved, Designed for Medical Use

KN95/FFP2 NR Filtering Facepiece Respirator, Non-NIOSH Approved, Designed for Medical Use
KN95/FFP2 NR Filtering Facepiece Respirator, Non-NIOSH Approved, Designed for Medical Use
KN95/FFP2 NR Filtering Facepiece Respirator, Non-NIOSH Approved, Designed for Medical Use
KN95/FFP2 NR Filtering Facepiece Respirator, Non-NIOSH Approved, Designed for Medical Use
KN95/FFP2 NR Filtering Facepiece Respirator, Non-NIOSH Approved, Designed for Medical Use
KN95/FFP2 NR Filtering Facepiece Respirator, Non-NIOSH Approved, Designed for Medical Use
KN95/FFP2 NR Filtering Facepiece Respirator, Non-NIOSH Approved, Designed for Medical Use
KN95/FFP2 NR Filtering Facepiece Respirator, Non-NIOSH Approved, Designed for Medical Use
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⚠️ Read the Warning Below

HIGH FILTRATION EFFICIENCY - With a 95% Bacterial and Particle Filtration Efficiency, the Catalyst KN95 has a filtration performance that is similar to US N95.

BEST FOR PROCEDURES WITH LOW RISK OF FLUID EXPOSURE - The fluid resistance (80mm/Hg) makes this respirator suitable for patient care and procedures during which a low amount of fluid is emitted.

INTERNATIONAL STANDARDS - This respirator has been tested against US, EU, and Chinese standards to ensure the best quality is being offered. 

STRINGENT QUALITY CONTROL - Thanks to the help of its Chinese in-house team and of FDA expert consultants, Catalyst is controlling the quality and compliance of its products. We only work with accredited laboratories, such as Nelson Lab, and reliable partners.

EUA BY THE FDA - This product has been authorized under Emergency Use Authorization (EUA) by the FDA. 


    Specifications


    WARNING

    • This respirator helps protect against certain particles. Misuse may result in sickness or death. For proper use, read the User Instructions. Not intended for individual resale. This CATALYST® respirator has not been FDA cleared or approved. This respirator has been authorized by FDA under an Emergency Use Act. This respirator is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of PPE under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
    • This respirator helps protect against certain particles. Misuse may result in sickness or death. For proper use, read the User Instructions. Not intended for individual resale. This CATALYST® respirator has not been FDA cleared or approved. This respirator has been authorized by FDA under an Emergency Use Act. This respirator is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of PPE under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.


    DESCRIPTION

    • The Non-NIOSH Approved Disposable KN95 Filtering Facepiece Respirator is designed to help provide respiratory protection for the wearer. Heat sealing technology binds 3 layers together to allow for Bacterial Filtration Efficiency (BFE) and Particulate Filtration Efficiency (PFE) ≥ 95%. It is also resistant to non-oil based fluids (80mm/Hg). The respirator is designed with non-woven fabric (polypropylene) which allows for particulate filtration and moisture-resistance. The 3D design allows for comfort, space and breathability. The nylon and spandex ear loops provide comfort for the wearer.
    • The Non-NIOSH Approved Disposable KN95 Filtering Facepiece Respirator is designed to help provide respiratory protection for the wearer. Heat sealing technology binds 3 layers together to allow for Bacterial Filtration Efficiency (BFE) and Particulate Filtration Efficiency (PFE) ≥ 95%. It is also resistant to non-oil based fluids (80mm/Hg). The respirator is designed with non-woven fabric (polypropylene) which allows for particulate filtration and moisture-resistance. The 3D design allows for comfort, space and breathability. The nylon and spandex ear loops provide comfort for the wearer. 


    FEATURES

    • Model: D30013
    • KN95 (GB2626-2006)
    • BFE and PFE ≥ 95%
    • Non-oil based fluid resistance (80mm/Hg)
    • Adjustable Nose Clip for fitting and a secure seal
    • Single-use
    • Foldable for easy storage prior to use
    • 3D Design allows for space, comfort and breathability
    • 3 Layers of non-woven material
    • Individual packaging
    • Vertical Flat Folded Design
    • Non-flammable 16 CFR 1610
    • Model: D30013
    • KN95 (GB2626-2006)
    • BFE and PFE ≥ 95%
    • Non-oil based fluid resistance (80mm/Hg)
    • Adjustable Nose Clip for fitting and a secure seal
    • Single-use
    • Foldable for easy storage prior to use
    • 3D Design allows for space, comfort and breathability
    • 3 Layers of non-woven material
    • Individual packaging
    • Vertical Flat Folded Design
    • Non-flammable 16 CFR 1610


    MATERIAL

    • Exterior Layer: Non-woven fabric (Polypropylene)

    • Interior Layer: Non-woven fabric (Polypropylene)

    • Middle Layer: Melt blown non-woven fabric (polypropylene)

    • Nose Clip: Iron and Polypropylene

    • Ear Loops: Nylon and Spandex

    • These respirators do not contain components made from natural rubber latex.

    • Exterior Layer: Non-woven fabric (Polypropylene)

    • Interior Layer: Non-woven fabric (Polypropylene)

    • Middle Layer: Melt blown non-woven fabric (polypropylene)

    • Nose Clip: Iron and Polypropylene

    • Ear Loops: Nylon and Spandex

    • These respirators do not contain components made from natural rubber latex.

    STANDARDS

    • US STANDARDS 

      • Main Regulation: ASTM F2100 - Standard Specification for Performance of Materials Used in Medical Face Masks 

      • Particle Filtration Efficiency ≥ 99%NIOSH TEB-APR-STP-0058, in accordance with 42 CFR part 84, as a N99 respirator (Nelson Lab)

      • Particle Filtration Efficiency ≥ 95%: ASTM F2299 - Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres

      • Bacterial Filtration Efficiency ≥95%: ASTM F2101 - Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials

      • Fluid Resistance: ASTM F1862 - Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)

      • Flammability: 16 CFR 1610 - Standard for the Flammability of Clothing Textiles

      • Breathability: Inhalation & Exhalation Resistance (Nelson Lab) - NIOSH procedure TEB-APR-STP-0007 & TEB-APR-STP-0003, in accordance with 42 CFR Part 84.180


    • EUROPEAN STANDARDS
      • Main regulation for respiratory protective devices (FFP2 NR) & Particle Filtration Efficiency ≥ 94%: : EN 149:2001+A1:2009 - This standard includes Particle Filtration ≥ 94%, Flammability & Skin Compatibility requirements.
         
      • Bacterial Filtration Efficiency ≥98%: EN 14683:2019 + AC:2019 (E), Type II R: Medical face masks - Requirements and test methods

      • REACH Compliant: EC 1907/2006 - 205 Substance of Very High Concern (SVHC) tested.

      • RoHS Compliant (Respirator + Polybag): Restriction of Hazardous Substances - Lead (Pb), Cadmium (Cd), Mercury (Hg), Hexavalent chromium (CrVI), polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE), and Phthalates (DEHP, BBP, BBP, DIBP).

      • Persistent Organic Pollutants (POPs): Regulation EU 2019/1021 - Hexabromocyclododecane (HBCDD), Short chain chlorinated paraffin (SCCP), Perfluorooctane sulfonic acid and its derivatives (PFOS) and Polychlorinated naphthalenes (PCNs).

      • CE - Standard EN 149:2001+A1:2009: Module C2 production monitoring for equipment within the scope of PPE Regulation 2016/425 Category III

      • EC Declaration of Conformity: Medical Device Directive (MDD) 93/42/EEC Class 1 (non-sterile)

      • Tested for 18 Polycyclic aromatic hydrocarbons (PAHs)

      • Skin Sensitization Test & Skin Irritation Test (non-woven fabric): ISO-10993-10 Guinea Pig Max. Test & Topical Application Directly

      • In Vitro Cytotoxicity Test of Non-Woven Fabric: ISO-10993-5 MTT Method


    • CHINESE STANDARDS
      • Main Regulation: GB2626-2006 - Mandatory National Standard GB 2626-2019 Respiratory Protection - Non-powered air-purifying particle respirator

      • Skin irritation Test: GB/T 16886.10-2017


    • US STANDARDS 

      • Main Regulation: ASTM F2100 - Standard Specification for Performance of Materials Used in Medical Face Masks 

      • Particle Filtration Efficiency ≥ 99%NIOSH TEB-APR-STP-0058, in accordance with 42 CFR part 84, as a N99 respirator (Nelson Lab)

      • Particle Filtration Efficiency ≥ 95%: ASTM F2299 - Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres

      • Bacterial Filtration Efficiency ≥95%: ASTM F2101 - Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials

      • Fluid Resistance: ASTM F1862 - Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)

      • Flammability: 16 CFR 1610 - Standard for the Flammability of Clothing Textiles

      • Breathability: Inhalation & Exhalation Resistance (Nelson Lab) - NIOSH procedure TEB-APR-STP-0007 & TEB-APR-STP-0003, in accordance with 42 CFR Part 84.180


    • EUROPEAN STANDARDS
      • Main regulation for respiratory protective devices (FFP2 NR) & Particle Filtration Efficiency ≥ 94%: : EN 149:2001+A1:2009 - This standard includes Particle Filtration ≥ 94%, Flammability & Skin Compatibility requirements.
         
      • Bacterial Filtration Efficiency ≥98%: EN 14683:2019 + AC:2019 (E), Type II R: Medical face masks - Requirements and test methods

      • REACH Compliant: EC 1907/2006 - 205 Substance of Very High Concern (SVHC) tested.

      • RoHS Compliant (Respirator + Polybag): Restriction of Hazardous Substances - Lead (Pb), Cadmium (Cd), Mercury (Hg), Hexavalent chromium (CrVI), polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE), and Phthalates (DEHP, BBP, BBP, DIBP).

      • Persistent Organic Pollutants (POPs): Regulation EU 2019/1021 - Hexabromocyclododecane (HBCDD), Short chain chlorinated paraffin (SCCP), Perfluorooctane sulfonic acid and its derivatives (PFOS) and Polychlorinated naphthalenes (PCNs).

      • CE - Standard EN 149:2001+A1:2009: Module C2 production monitoring for equipment within the scope of PPE Regulation 2016/425 Category III

      • EC Declaration of Conformity: Medical Device Directive (MDD) 93/42/EEC Class 1 (non-sterile)

      • Tested for 18 Polycyclic aromatic hydrocarbons (PAHs)

      • Skin Sensitization Test & Skin Irritation Test (non-woven fabric): ISO-10993-10 Guinea Pig Max. Test & Topical Application Directly

      • In Vitro Cytotoxicity Test of Non-Woven Fabric: ISO-10993-5 MTT Method


    • CHINESE STANDARDS
      • Main Regulation: GB2626-2006 - Mandatory National Standard GB 2626-2019 Respiratory Protection - Non-powered air-purifying particle respirator

      • Skin irritation Test: GB/T 16886.10-2017
    Documents


    Frequently Asked Questions

    ABOUT THIS RESPIRATOR

    WHAT LEVEL OF PROTECTION DOES THE RESPIRATOR PROVIDE?

      • Filtration Performance: The respirator is a certified KN95 (GB 2626-2006) respirator. This Chinese Standard certifies that a properly fitted respirator will filter at least 95% of very small ( 0.1μm) airborne particles. This is in line with the FDA requirements regarding materials used in medical face masks (ASTM F2100, Level 1)

      • Fluid Resistance: The respirator has been tested against synthetic blood sprayed at a pressure of 80mm/Hg (ASTM F1862). This is in line with the FDA requirements regarding materials used in medical face masks (ASTM F2100, Level 1)


    WHAT CAN THIS RESPIRATOR BE USED FOR? 

      • This product is intended to be worn by healthcare personnel to reduce wearer exposure to certain airborne particles that are free of oil. 

      • The respirator meets ASTM F1862 Level 1 requirements, which is most suited for procedures where low amounts of fluid, spray and/or aerosols are produced.


    TYPES OF RESPIRATORS

    WHAT IS THE DIFFERENCE BETWEEN A KN95 AND N95?

      • Regulatory entities: N95 is a US standard that is regulated by the National Institute for Occupational Safety and Health (NIOSH). KN95 (GB2626-2006) is a Chinese standard regulated by the Standardization Administration of the People's Republic of China (SAC).

      • Testing: Comparing both standards, the mask manufacturer 3M concluded that “it is reasonable to consider China’s KN95s “equivalent” to US N95s". 

        Both standards certify the filtration of at least 95% of non-oil airborne particles (PFE @ 0.1μm ≥ 95%). The methods used to assess the performance of the respirators vary slightly. 

        For example, the maximum pressure the masks must be able to withstand as a person breathes is different, requiring N95 to be slightly more breathable. Another difference is the fact that the KN95 Standard requires manufacturers to run fit tests on real humans with ≤ 8% leakage while NIOSH only requires employees to proceed to a fit test.

    WHAT DOES PFE STAND FOR? 

      • The Particles Filtration Efficiency (PFE) represents the percentage of very small particles (0.1 μm) that are filtred when they pass through the mask or respirator. 

    WHAT DOES BFE STAND FOR? 

      • The Bacterial Filtration Efficiency (BFE) represents the percentage of bacteria-sized particles (3 μm) that are filtred when they pass through the mask or respirator. 

    WHAT IS THE EMERGENCY USE AUTHORIZATION (EUA)? 

      • The Emergency Use Authorization (EUA) provides the FDA the authority to allow unapproved medical products or unapproved uses of approved medical products in case of an emergency when there are no adequate alternatives available. The authorization is only for the duration of the declaration of the circumstances existing justifying the authorization of the emergency use.

     

    HOW TO USE

    HOW SHOULD I PUT THE RESPIRATOR ON?

    1.  Hold the respirator with nosepiece facing away from you with one earloop strap in each hand.

    2.  Place the respirator on your face, touching your chin and nose.

    3.  Pull each strap over your ear and adjust to suit your comfort.

    4.  Mold the metal nosepiece to the shape of your nose using your fingertips using two hands

    5.  Test the seal of the respirator before use by cupping the respirator with both hands and exhale sharply. If air flows
    around your nose, tighten the nosepiece. If air leaks around the edges, re-position the straps for better fit.
     
     

    HOW SHOULD I REMOVE THE RESPIRATOR?

    1.  Remove the straps on your ears. Be careful not to touch the respirator with your hands.

    2.  Wash your hands after removing the respirator.