Catalyst 3 Ply Face Mask

PROTECT YOUR STAFF. MAKE CUSTOMERS FEEL SAFE

• The CDC recommends wearing a face mask as a simple barrier covering the mouth and nose. This can help prevent infected individuals from scattering respiratory droplets into the air and onto other people via coughing, coughs, sneezing, or talking.

  Aside from statutory requirements or unintended workforce interruptions, customers need to know that your business operates safely. Preventative mitigation reduces the risk of business interruption and related financial losses. See Note 1

   

  This face mask is to be used for source control only, and is not personal protective equipment. This is not a substitute for filtering facepiece respirators or surgical face masks. Businesses should consider also adding another barrier of protection with a face shield to complement the use of this face mask, when sustained close contact with customers or other employees is unavoidable and necessary.

• The face mask is constructed using a 3-ply design, providing greater breathability and comfort for the wearer. The Spandex and Nylon ear loops are comfortable and resist up to 10N force. The built-in nose clip adjusts fit to the shape of the nose and avoids gaps in protection and fogging for eyeglass wearers.
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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
  

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

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

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

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

DOCUMENTS

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

RESOURCES ON COVID-19 & EUAs

• General: CDC website & FDA website
  
  
• Healthcare Professionals: CDC website
  
  
• Infection Prevention and Control Recommendations in Healthcare Settings: CDC website
  
  
• Recommendations on the use of face masks by the general public during COVID-19: CDC website
  
  
• EUAs: FDA website, Manufacturer's instructions & Patient Fact Sheet

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. 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. 
  
  
• 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.

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.
  
  

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 SHOULD I PUT THE FACE MASK ON?

1. Wash your hands before putting on the face mask.
2. With one ear loop strap in each hand, hold the face mask with its nose piece facing away from you
3. Place the face mask on your face, touching your chin and nose.
4. Pull each ear loop over your ear and adjust to suit your comfort.
5. Mold the metal nose piece to the shape of your nose with your fingertips, using both hands.
6. Test the seal of the face mask before use by cupping the respirator with both hands and exhaling sharply. If air flows around your nose, tighten the nosepiece. If air leaks around the edges, reposition the ear loops for a tighter fit.