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Catalyst Face Mask

Catalyst Face Mask
Catalyst Face Mask
Catalyst Face Mask
Catalyst Face Mask
Catalyst Face Mask
Catalyst Face Mask
Catalyst Face Mask
Catalyst Face Mask
Catalyst Face Mask
Catalyst Face Mask
Catalyst Face Mask
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PROTECT YOUR BUSINESS. MAKE CUSTOMERS FEEL SAFE - According to the CDC, COVID-19 spreads mainly among people who are in close contact with one another (within about 6 feet), so it is important to practice social distancing (staying at least 6 feet away from other people). However, in some businesses or some business operations, it may be difficult to avoid close contact with customers or other employees. Aside from statutory requirements or unintended workforce interruptions, customers need to know that your business operates safely, and this impacts their willingness to transact with you. Preventative mitigation reduces the risk of business interruption and related financial losses. See Note 1

EXTRA PROTECTION FOR STAFF AGAINST DROPLETS & RESPIRATORY EMISSIONS – The CDC recommends wearing a face mask for source control, which means that the face masks act as a simple barrier covering the mouth and nose to prevent infected individuals, who may or may not have symptoms of COVID-19, from scattering respiratory droplets into the air and onto other people when the person wearing the face mask coughs, sneezes, talks, or raises their voice. This face mask is to be used for source control only, and is not personal protective equipment, meaning this is not a substitute for filtering facepiece respirators or for surgical face masks. Businesses should consider also adding another barrier of protection by using a face shield to complement the use of this face mask, when sustained close contact with customers or other employees is unavoidable and necessary. 

INTERNATIONAL STANDARDS & STRINGENT QUALITY CONTROL - The CATALYST® Face Mask has been tested against US, EU, and Chinese standards and is manufactured in a facility that is ISO 13485 certified. Our on-the-ground team conducts engineering, evaluation, development, production, quality control and quality assurance. We have also validated this product through testing at accredited independent third party test labs and reviewed 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.

FDA EMERGENCY USE AUTHORIZATION ONLY- The CATALYST® Face Mask is authorized in the US by the FDA for use by the general public and health care personnel for source control.  The FDA has not reviewed, cleared or approved this product for any other purpose.  The authorization is in effect for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices during the COVID-19 outbreak, under section 564(b)(1) of the Food Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. See Note 2

3-PLY DESIGN WITH EAR LOOPS AND ADJUSTABLE NOSE CLIP - The respirator is constructed using a 3-ply design that provides greater breathability and comfort for the wearer. The Spandex and Nylon ear loops are comfortable and resist up to 10N force. Use the built-in nose clip to adjust fit to the shape of the nose to avoid gaps in protection around the nose and to avoid fogging for eyeglass wearers. Can be used with a Catalyst Comfort Extender to help employees wear the face mask comfortably for extended periods of time and reduce ear pain.



Specifications


FEATURES

  • Model number: 9001
  • Good breathability for comfortable wear
  • Adjustable nose clip for a more secure seal and eyewear fogging prevention
  • Made of 3 layers of non-woven material
  • Adult size
  • 3-ply design allows for space, comfort and breathability
  • Comfortable and flexible ear loops with strong fixation
  • Single-use, disposable
  • Model number: 9001
  • Good breathability for comfortable wear
  • Adjustable nose clip for a more secure seal and eyewear fogging prevention
  • Made of 3 layers of non-woven material
  • Adult size
  • 3-ply design allows for space, comfort and breathability
  • Comfortable and flexible ear loops with strong fixation
  • Single-use, disposable


    STANDARDS (This data has not been reviewed by the FDA)

    • EN-14683 Class I (Non-sterile): Medical face masks (EU)
    • YY/T0469-2011: Surgical Mask (CN)
    • ASTM F2100-2019: Standard Specification for Performance of Materials Used in Medical Face Masks
    • CE Declaration of Conformity: Medical Devices Directive 93/42/EEC

     


    • EN-14683 Class I (Non-sterile): Medical face masks (EU)
    • YY/T0469-2011: Surgical Mask (CN)
    • ASTM F2100-2019: Standard Specification for Performance of Materials Used in Medical Face Masks
    • CE Declaration of Conformity: Medical Devices Directive 93/42/EEC


      MATERIAL

      • Exterior Layer: Non-woven fabric (Polypropylene)
      • Interior Layer: Non-woven fabric (Polypropylene)
      • Middle Layer: Melt blown non-woven fabric (polypropylene)
      • Nose Clip: Iron + Polypropylene
      • Ear Loops: Nylon + Spandex

       


      • Exterior Layer: Non-woven fabric (Polypropylene)
      • Interior Layer: Non-woven fabric (Polypropylene)
      • Middle Layer: Melt blown non-woven fabric (polypropylene)
      • Nose Clip: Iron + Polypropylene
      • Ear Loops: Nylon + Spandex


      MANUFACTURER

      • Manufactured for CATALYST® by: Zhangzhou Easepal Industrial Co., Ltd. Medical Equipment Branch

        Address: 4th Floor, No. 228 JiaoSong Road, Jiaomei Town, 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

      • Manufactured for CATALYST® by: Zhangzhou Easepal Industrial Co., Ltd. Medical Equipment Branch

        Address: 4th Floor, No. 228 JiaoSong Road, Jiaomei Town, 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


      DOCUMENTS

      • Information Sheet (TBD)

      • User Instructions (TBD)

      • Patient Fact Sheet (TBD)
      • Information Sheet (TBD)

      • User Instructions (TBD)

      • Patient Fact Sheet (TBD) 

      RESOURCES ON COVID-19 & EUAs

          NOTES

          • Note 1: According to the CDC, COVID-19 spreads mainly from person to person through respiratory droplets and COVID-19 can be spread by people who do not have symptoms and do not know that they are infected so they are “asymptomatic”. Merely isolating people who show symptoms is insufficient in containing the spread in businesses.

          • Note 2: This CATALYST® Face Mask is not personal protective equipment. Health care facilities should not purchase or offer these masks as substitutes for surgical masks or filtering facepiece respirators. This Face mask should NOT be used in place of surgical masks or filtering facepiece respirators to provide protections such as: liquid barrier protection; antimicrobial or antiviral protection, prevention, or reduction; respiratory protection; Particulate filtration; protection in high-risk Aerosol Generating Procedures. Source: www.fda.gov

          • This CATALYST® Face Mask is not intended for use by a Healthcare Provider as PPE and does not meet the requirements for healthcare employers to meet the federal and state standards of the Occupational Safety and Health Administration (OSHA) that apply to PPE to protect workers and infectious disease hazards. See 29 CFR 1910 subpart I., Healthcare employers should refer to the CDC’s Strategies to Optimize the Supply of PPE and Equipment and the CDC’s Strategies for Optimizing the Supply of Facemasks. If the alternative is wearing no mask and all other options have been exhausted, this face mask would fall under the use as a Crisis Capacity Strategy in the CDC prioritization table for use “When No Facemasks Are Available” under “HCP use of homemade masks” and should ideally be used in combination with a face shield that covers the entire front (that extends to the chin or below) and sides of the face.
          • Note 1: According to the CDC, COVID-19 spreads mainly from person to person through respiratory droplets and COVID-19 can be spread by people who do not have symptoms and do not know that they are infected so they are “asymptomatic”. Merely isolating people who show symptoms is insufficient in containing the spread in businesses.

          • Note 2: This CATALYST® Face Mask is not personal protective equipment. Health care facilities should not purchase or offer these masks as substitutes for surgical masks or filtering facepiece respirators. This Face mask should NOT be used in place of surgical masks or filtering facepiece respirators to provide protections such as: liquid barrier protection; antimicrobial or antiviral protection, prevention, or reduction; respiratory protection; Particulate filtration; protection in high-risk Aerosol Generating Procedures. Source: www.fda.gov

          • This CATALYST® Face Mask is not intended for use by a Healthcare Provider as PPE and does not meet the requirements for healthcare employers to meet the federal and state standards of the Occupational Safety and Health Administration (OSHA) that apply to PPE to protect workers and infectious disease hazards. See 29 CFR 1910 subpart I., Healthcare employers should refer to the CDC’s Strategies to Optimize the Supply of PPE and Equipment and the CDC’s Strategies for Optimizing the Supply of Facemasks. If the alternative is wearing no mask and all other options have been exhausted, this face mask would fall under the use as a Crisis Capacity Strategy in the CDC prioritization table for use “When No Facemasks Are Available” under “HCP use of homemade masks” and should ideally be used in combination with a face shield that covers the entire front (that extends to the chin or below) and sides of the face.

            Frequently Asked Questions

            ABOUT THE CATALYST® FACE MASK COMFORT EXTENDER

             

            WHY SHOULD I WEAR A FACE MASK?

              • According to the CDC, COVID-19 spreads mainly among people who are in close contact with one another (within about 6 feet) through respiratory droplets and COVID-19 can be spread by people who do not have symptoms and do not know that they are infected so they are “asymptomatic”. Merely isolating people who show symptoms is insufficient in containing the spread in businesses.

             

            WHAT CAN THIS FACE MASK BE USED FOR?

              • The CATALYST® Face Mask is authorized in the US by the FDA for use by the general public and health care personnel for source control only, which means that the face masks act as a simple barrier covering the mouth and nose to prevent infected individuals, who may or may not have symptoms of COVID-19, from scattering respiratory droplets into the air and onto other people when the person wearing the face mask coughs, sneezes, talks, or raises their voice. 
              • It is not personal protective equipment, meaning this is not a substitute for filtering facepiece respirators or for surgical face masks.
              • This CATALYST® Face Mask is not intended for use by a Healthcare Provider as PPE and does not meet the requirements for healthcare employers to meet the federal and state standards of the Occupational Safety and Health Administration (OSHA) that apply to PPE to protect workers and infectious disease hazards. See 29 CFR 1910 subpart I., Healthcare employers should refer to the CDC’s Strategies to Optimize the Supply of PPE and Equipment and the CDC’s Strategies for Optimizing the Supply of Facemasks. If the alternative is wearing no mask and all other options have been exhausted, this face mask would fall under the use as a Crisis Capacity Strategy in the CDC prioritization table for use “When No Facemasks Are Available” under “HCP use of homemade masks” and should ideally be used in combination with a face shield that covers the entire front (that extends to the chin or below) and sides of the face.

             

            WILL THE EAR LOOPS FALL OFF?

              • The ear loops attachment point has been tested and passed a pull force test up to 10 Newton Force. When used properly, with no excessive force applied, the ear loop should not fall off.

              • 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

             

            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.

              • The CATALYST® Face Mask is authorized in the US by the FDA for use by the general public and health care personnel for source control.  The FDA has not reviewed, cleared, or approved this product for any other purpose.  The authorization is in effect for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices during the COVID-19 outbreak, under section 564(b)(1) of the Food Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.



            COMPATABILITY

            WHO IS IT SUITABLE FOR?

              • The Catalyst Face Mask is designed for adults. It may not fit children's faces. The face mask shouldn’t be used by children younger than 2 years old or by anyone who has trouble breathing or is unconscious, incapacitated, or otherwise unable to remove the face mask without assistance. It shouldn’t be used in situations where a face covering may exacerbate a physical or mental health condition, lead to a medical emergency, or introduce significant safety concerns.


            CAN I WEAR THE CATALYST FACE MASK WITH GLASSES?

              • The Catalyst Face Mask can be worn together with most types of eyewear. It is designed with a built-in nose clip that allows adjusting the fit of the mask to the shape of the nose. This helps prevent air from leaking by the top and hence reduces the fogging of eyewear.

               

              HOW TO USE

              HOW SHOULD I PUT THE FACE MASK ON?

              1. Wash your hands before putting on the face mask.
              2. Hold the face mask with one ear loop strap in each hand, with the darker shade of blue facing away from you and the nosepiece at the top.
              3. Place the face mask on your face, fully covering your chin and nose. 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. 

              Consider the use of the Catalyst Face Mask Comfort Extender to extend the ear loops around the head and relieve the eventual ear pain that may occur during extended wear.

               

              HOW SHOULD I REMOVE THE FACE MASK?

              1. Remove the face mask using both hands, by holding and stretching the ear loops. Be careful not to touch the outside front of the face mask with your hands or hair
              2. Wash your hands after removal.