Disposable KN95 Non-NIOSH Approved Filtering Facepiece Respirator

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.

EMERGENCY USE AUTHORIZATION BY THE FDA

• This Respirator has been authorized by the FDA for sale via an EUA for use during the period of shortage caused by the COVID-19 pandemic. See Note 1

PFE & BFE ≥ 95%

• Designed to help protect the wearer from exposure to patient-generated airborne viruses and bacteria.  Made with 3 layers of non-woven material, this respirator has a 95% filtration efficiency of 0.3 micron particles, meeting the Chinese Standard GB 2626-2006, KN95 (See Note 2a). The filtration efficiency of this respirator has been evaluated using methods similar to those used by NIOSH and is still expected to provide adequate protection for healthcare personnel (See Note 2b).

DESIGNED TO FIT TIGHTLY AND SEAL AROUND THE FACE

• This KN95 respirator is constructed using a Vertical Flat Folded Design that that is packaged flat, with a vertical fold through the middle, but opens up into a cup shape that is designed to provide a seal preventing air from leaking around the edges. This respirator also features a metal noseclip folded in half at the top of the facepiece and 2 spandex/nylon ear loop bands that resist up to 10N force. See Note 3

LEVEL 1 FLUID RESISTANCE

• Passes non-oil based fluid resistance (80mm/Hg). This respirator is suitable for patient care and procedures during which a low amount of fluid is emitted. Not suitable for surgical use. See Note 4.

INTERNATIONAL STANDARDS & STRINGENT QUALITY CONTROL

• Manufactured in a FDA registered facility that is ISO 13485 certified, this respirator has been tested against US, EU, and Chinese standards. See Note 5.

NOTES

• Note 1:
• This respirator is to be used as a Crisis Capacity Strategy in the CDC prioritization table for use “when N95 supplies are running low” according to the CDC's strategies for optimizing respirator supply 
• This KN95 meets a Chinese government standard similar to NIOSH-approved respirators for an equivalent filtration efficiency performance comparable to N95. This respirator has obtained both a marketing authorization under the NMPA registration certification for China and CE mark authorized by a competent notified body for respiratory protective equipment within the scope of Regulation (EU) 2016/425 for Europe.
• This respirator should only be used in crisis situations when no other NIOSH-approved N95 respirator (or a listed device from one of the other countries identified within the FDA EUA) is available.
• This respirator should not be used during aerosol-generating medical procedures unless the alternative is a loose-fitting surgical mask or improvised device, and a fit test is performed prior to use.
  
  
• Note 2:
• 2a: This respirator is meeting the Chinese Standard GB2626-2006 (KN95), as a part of the “Standards Used in Other Countries That Are Similar to NIOSH-Approved N95 Filtering Facepiece Respirators”. (Source: CDC)
  
  
• 2b: In accordance with the EUA guidelines, samples of these respirators have also been tested by the CDC’s National Personal Protective Technology Laboratory (NPPTL) for particulate filter efficiency using a modified version of NIOSH Standard Test Procedure (STP) TEB-APR-STP-0059. The Filter Penetration Performance has been tested by the NPPTL, a division operating within NIOSH and the CDC (US): View report. 
  
  
• Note 3: 
• While most NIOSH-approved N95s typically have head bands, it is common for respirators in Asia to have ear loops and NIOSH states that “limited assessment of ear loop designs indicate difficulty achieving a proper fit. While filter efficiency shows how well the filter media performs, users must ensure a proper fit is achieved.” Source: CDC. 
• This design tends to fit people with facial features common in China and other countries in Asia and may not be able to achieve a satisfactory fit for all customers users. To provide the expected level of protection, this respirator must be fit tested as part of an overall respiratory protection program in accordance with requirements under OSHA Respiratory Protection standard (29 CFR 1910.134) to ensure that it seals to the wearer’s face, without allowing air leaks to pass through gaps between the respirator and the wearer’s skin. In addition, individuals should read and follow all user instructions, including conducting a user seal check every time they put on a respirator. If a fit test cannot be conducted, or the wearer cannot pass a fit test, then these products should be used as a facemask, not a respirator.
  
  
• Note 4: This respirator is not suitable for use in a sterile field or in environments with exposure to high velocity splashes, sprays, or splatters of blood or body fluids, such as in operative or procedural settings. The CDC recommends the use of a Surgical N95 in these settings and a level 3 fluid resistance is required for FDA approval of a surgical N95 respirator. If using in a surgical environment due to a lack of alternatives, it is recommended that you use a face shield approved for medical use with this respirator.
  
  
• Note 5: Tested against Chinese standards by laboratories that are ISO/IEC 17025 accredited, by a test lab accredited to act as a notified body for Regulation (EU) 2016/425 Personal protective equipment The European Union Commission website provides a link to the list of Notified Bodies for Personal Protective Equipment in Europe – bodies notified under Regulation (EU) 2016/425 on personal protective equipment. Our on-the-ground team conducts engineering, evaluation, development, production, quality control and quality assurance. We have also validated this product for regulatory compliance, working with a team of regulatory consultants and lawyers with decades of experience conducting medical device reviews with the FDA.
• Not made with latex rubber 

FEATURES

• Model: D13003
• 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.

STANDARDS

• US STANDARDS 
  
  
• Main Material Standard: 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: Level 1 (80mm/Hg) 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

MANUFACTURER

• Manufactured For Rogue Lemmings, Inc. DBA Catalyst by: Medical Device Branch of Zhangzhou Easepal Industrial Co., Ltd.4th Floor of Building #7, No.228, Jiaosong Road, Taiwanese Investment Zone, Zhangzhou, Fujian, China

• Report Adverse events, including problems with test performance or results, to MedWatch by submitting the online FDA Form 3500 (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) or by calling 1-800-FDA-1088

• Information Sheet 

• User Instructions 

• Fact Sheet for Healthcare Personnel

• Masks & Respirators: Comparison Chart

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 (0.3μm) 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.
  

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.

IS THIS RESPIRATOR NIOSH-APPROVED?

No, this CATALYST® respirator has not been approved by NIOSH. 

This 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.

WHY DOES THIS RESPIRATOR NOT LOOK LIKE REGULAR RESPIRATORS

The Catalyst KN95 is constructed in a Vertical Flat Folded Design. This design is common for KN95 respirators and is primarily designed to suit Asian faces. Proceed to the mandatory OSHA Fit Test before using the respirator. 

NIOSH-approved respirators historically don’t have ear loops. It is however common for KN95 to be constructed with ear loops. Consider the use of the Catalyst Comfort Extender to extend the ear loops around the head and relieve the eventual ear pain that may occur during extended wear.

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: In its 'Strategies for Optimizing the Supply of N95 Respirators', as part of its Crisis Capacity Strategies, the CDC listed the Chinese Standard GB 2626-2006 (KN95) as part of the “Standards Used in Other Countries That Are Similar to NIOSH-Approved N95 Filtering Facepiece Respirators”. The CDC explained that KN95s are evaluated using some methods that are similar to those used by NIOSH and are expected to provide protection similar to NIOSH-approved filtering facepiece and elastomeric respirators.
  Both standards certify the filtration of at least 95% of non-oil airborne particles (PFE ≥ 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 sub-micron level particles 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. 

 HOW SHOULD I PUT THE RESPIRATOR ON?