Face Shield

EMERGENCY USE AUTHORIZATION BY THE FDA

• The Catalyst Face Shield has been authorized by the FDA for sale via an Emergency Use Authorization (EUA) for use during the period of shortage caused by the COVID-19 pandemic. Click the FAQ tab for more details.

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 practicing social distancing by staying at least 6 feet away from other people is important. However, in some businesses, it may be difficult to social distance 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. Click the FAQ tab for more details.

FULL-LENGTH FACE PROTECTION

• Employees, that have long periods of sustained close contact, should wear a face shield that covers the entire front (that extends to the chin or below) and sides of the face in combination with a face mask or face covering to reduce the risk of respiratory transmission from when a person coughs, sneezes, talks, or raises their voice. The face shield is also lightweight and comfortable. The foam headband and elastic headband are comfortable and keep the face shield from touching your face, so you can wear glasses if needed and also has an anti-fog and an anti-static treatment on the surface. Ensure that the plastic film on the face shield is removed before use. Click the FAQ tab for more details.

CLEANABLE

• Should be cleaned and disinfected after each use. Use a disinfecting wipe, hand sanitizer or a clean cloth saturated with an EPA approved disinfecting solution with an active ingredient of 70% isopropyl alcohol or 70% ethanol (which are generally compatible with the hard surface materials of the face shield). Use of other disinfectants is not recommended.

HIGH-QUALITY CONTROL STANDARDS

• Manufactured in a facility that is ISO 9000/9001 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.

FEATURES

• Model: 2001
• Protects face, eyes, mouth, nose from fluids, and particles
  
• Made of super transparent, recyclable PET (Polyethylene terephthalate) allowing for clear vision
  
• Anti-fog treatment on inside and outside of shield
  
• 1.5” foam headband holds shield away from face
  
• Elastic headband to provide comfort to the wearer
• One size fits all
• Single-use, disposable
• Optimal visibility
• Anti-static treatment

MATERIAL

• Shield: Polyethylene Terephthalate (PET)

• Foam headband: Polyurethane (PU)

• Elastic headband: Rubber & Polyester

• Plastic knobs x 2: Polypropylene (PP)

STANDARDS

• ANZI/ISEA Z87.1 (USA)
• EN-166 (EU)
• GB14866-2006 (CN)

DOCUMENTS

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

WHY SHOULD SOMEONE WEAR A FACE SHIELD?

• 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.

WHAT LEVEL OF PROTECTION DOES THIS FACE SHIELD PROVIDE?

• Fluid Resistance: This face shield has been tested to protect the wearer's eyes and face against exposure to bodily fluids, liquid splashes, or potentially infectious material. This is in line with the FDA requirements regarding materials used in Occupational And Educational Personal Eye And Face Protection Devices (ANSI/ISEA Z87.1-2020 (USA))

WHAT CAN THIS FACE SHIELD BE USED FOR?

• The Catalyst® Face Shield is to be worn to protect the user’s eyes and face from exposure to bodily fluids, liquid splashes, or potentially infectious material.
  
  
• This Face Shield falls under the CDC Strategies for Optimizing the Supply of Eye Protection as a “Contingent Capacity Strategy” in the CDC prioritization table for use "Implement extended use of eye protection" and should ideally be used in combination with a respirator or face mask with the face shield covering the entire front (that extends to the chin or below) and sides of the face and can be considered to provide protection equivalent to a Level 1 protection standard ANSI/AAM IPB70.
  
  
• The Face Shield is not a substitute for a face mask or face covering. If due to a lack of alternatives, a face shield is used without a mask, it should wrap around the sides of the wearer’s face and extend to below the chin. Source: CDC
  
  
• Pursuant to Section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, it is reasonable to believe that face shields may be effective at preventing HCP exposure to certain particulates during face shield shortages by providing minimal or low barrier HCP protection to the wearer during COVID-19, when used consistently with the Scope of the Emergency Use Authorization, pursuant to Section 564(c)(2)(A) of the Act. FDA has reviewed the scientific information available to FDA, and concludes that face shields for use by HCP as PPE (as described in the EUA), meet the criteria set forth in Section 564(c) of the Act concerning safety and potential effectiveness. Face shields can be intended for medical or nonmedical (e.g., industrial) purposes. Face shields intended for a medical purpose are regulated by FDA under 21 CFR 878.4040 – Surgical apparel. These devices are classified as class I (general controls) and are exempt from the premarket notification requirements in 21 CFR Part 807 (“510(k) clearance”). 

WHAT IS THE EMERGENCY USE AUTHORIZATION?

• According to the FDA, there are not sufficient quantities of face shields to meet the needs of the U.S. healthcare system. These articles of PPE are an integral part of patient care during the COVID-19 pandemic, particularly during Aerosol Generating Procedures, such as intubation of patients prior to administration of mechanical ventilation. Providing authorization for the introduction into interstate commerce of face shields by manufacturers that do not customarily engage in the manufacture of medical devices helps meet the needs of the healthcare system. Providing Healthcare Providers who are on the forefront of the COVID-19 response with sufficient PPE is necessary in order to reduce the risk of illness in HCP and increase their availability to provide care to affected patients or those suspected of having COVID-19.
• The FDA has issued an EUA for this product to increase the availability of face shields for medical purposes during the COVID-19 pandemic because there are insufficient quantities of face shields to meet the needs of the U.S. healthcare system. 

IS THIS FACE SHIELD REUSABLE?

• The face shield has been created to be disposable. However, in accordance with the FDA and CDC's guidance, in the absence of other alternatives, this Face Shield may be cleaned and reused following the CDC's recommendations for "Selected Options for Reprocessing Eye Protection" and the User Instructions for this product*. For multiple uses by the same user, reuse following cleaning instructions. The Centers for Disease Control (CDC) does not recommend this strategy as it is not standard practice.
  

•  If adopted:

  • A face shield should be used by one person.
  • They should be immediately cleaned when they are visibly soiled, whenever they are removed, and at least daily, prior to putting them back on.
  • After cleaning, the face shield should be stored in a transparent plastic container and labeled to prevent accidental sharing between users.

  
  

  Note: The number of times a disposable face shield could potentially be cleaned is unknown; therefore, face shields should be closely examined prior to each reuse to ensure the integrity of the foam headband, elastic strap, and clarity of the shield. *

  *For more information, Please visit: https://www.cdc.gov/coronavirus/2019-ncov/hcp/non-us-settings/emergency-considerations-ppe.html

WHO CAN WEAR THE CATALYST® FACE SHIELD?

• The Catalyst® Face Shield can be worn by most adults. 

CAN I WEAR THE FACE SHIELD WITH GLASSES ON?

• Yes, glasses can be worn with the Catalyst® Face Shield. For more information on how to fix glasses while wearing the face shield, please refer to the HOW TO USE section below.

HOW SHOULD I PUT ON THE FACE SHIELD?

1. Starting from the bottom right corner of the front of the Catalyst® Face Shield, gently peel off protective film towards the top half where the pattern is printed. When removing the film from the top section where the pattern print is, hold and clamp each plastic rivet in between 2 fingers and gently peel the film off around each plastic rivet. Be careful not to pull too hard on the rivets to avoid loosening the attachment point for the elastic band. Next, peel the protective film from the inside surface of the face shield by gently peeling the film off starting from the section just under the foam headband.
2. Inspect the face shield before each use and dispose of immediately upon discovery of damage or altered parts that prevent proper fit (e.g., The face shield can no longer fasten securely to the head.) 
3. Position the face shield over the face and secure it on the head using the attached headband. Adjust to fit comfortably.  
4. Ensure the face shield does not interfere with the correct positioning or fit of a face mask, face covering, or respirator. The face shield should wrap around the sides of the wearer’s face and extend to below the chin. Do not touch the face shield after you have put it on. 
5. For users wearing corrective eyewear, wash and disinfect hands prior to any adjusting of the corrective eyewear. Adjust corrective eyewear by adjusting from the frame of the eyewear above the ear. Do not touch the front of the face shield.
6.  Remove and follow cleaning instructions if the face shield becomes visibly soiled or difficult to see through. If you touch or adjust the face shield, you must immediately perform hand hygiene. Ensure you are 6 feet away from others and avoid close contact with others if you need to remove the face shield.