Personal Protective Equipment under the EUA and Appendix A

What is the FDA Authorized Appendix A list under the EUA, and why is it important?

What is the EUA?

The EUA or Emergency Use Authorization is evoked during public health emergencies like COVID-19. Through this authorization, the Food and Drug Administration tries to make sure that the public and the medical field have enough medical devices to manage the crisis. They do this by allowing unapproved medical products or medical products that are approved for one use to be used in a different setting to prevent shortages.

Surgical Masks and Non-NIOSH Respirators Under Appendix A

Appendix A PPE

There are two products in Appendix A: surgical masks and non-NIOSH respirators that are made in China.

This is important because you want to know that the mask you are wearing is effective- especially in a pandemic.

So, the FDA has tested and continues to test certain categories of masks to get them on Appendix A to say they are approved for use in a medical setting.

How Do Products Get Put on the EUA?

Companies who want their product to be listed and certified under the EUA can apply for their products to be tested. There is a specific testing protocol that the FDA, in collaboration with the CDC, uses in order to approve products.

Is Your KN95 Mask or other PPE Listed Under the EUA?

If you want to check if the products you are using are certified under the EUA and Appendix A, follow the link and scroll to find your brand.

Learn More About EUA, Appendix A, and PPE

If you are looking for personal protective equipment for yourself or your business, MF Supply has KN95 Respirator Masks and more PPE. Contact us today to learn more!


Back to Work Guidance – Safety and 4 PPE Products

Safely Reopening, Restarting, Renormalizing

New Jersey entered Stage Two of our recovery as Outdoor Dining and Indoor, Non-Essential Retail opened on June 15. On June 22 Hair Salons and Barber Shops Reopened. I had my first meal in a restaurant last week! I got to see the new Safety rules in action first hand. The servers and waitstaff wore assorted PPE including 3-Ply masks and rubber gloves that were changed constantly in order to minimize cross contamination.

Many of our customers have asked for help determining what PPE they should provide to their workforce. We like the NJMEP 2020 Return to Work and Recovery Guide published June 23, 2020. Below, we’ve summarized guidance taken from expert sources on the use of masks, respirators, gloves and hand sanitizer. It includes a chock full of information from experts that can help you return to work safely and compliantly.


Before you chose to implement any of the ideas suggested in thisdocument you must evaluate and determine, with the assistanceof your legal counsel, accounting and human resource teams, thelegality and effectiveness of the potential application captured in thisdocument.

FACE MASK OPTIONS

Many states require workers and customers to wear protective face coverings while on the premises or in the office. The CDC recommends wearing cloth face coverings in public settings where other social distancing measures are difficult to maintain, especially in areas of significant community transmission. Cloth face coverings may prevent people who don’t know they have the virus from transmitting it to others. These face coverings are not surgical masks or respirators and are not appropriate substitutes for them in workplaces where masks or respirators are recommended or required.


Many organizations are providing Disposable 3-Ply Face Masks to their customers and staff. These Civilian Grade disposable masks that resemble Surgical masks are designed to filter out airborne germs, particulates, pollen, bacterial particles and droplets common in daily life. They are splash resistant, and reduce the risk of most droplets and secretions exhaled by the wearer from contaminating their surroundings. They should be constructed of non-woven polypropylene and electrostatic melt blown cloth. If they are China made, they should be certified to the standard GB/T 32610-2016. We recommend 3-Ply Civilian masks that are FDA Registered with lab test reports showing Bacterial Filtration Efficiency (BFE) of 90% of greater.

Please Note: Employees should continue to follow their routine policies and procedures for PPE (if any) that they would ordinarily use for their job tasks.

N95s & KN95 RESPIRATOR MASK GUIDANCE

N95 or alternative Respirator Masks including KN95s are appropriate for the following workers:

  • Employees with Broad Exposure
  • Cafeteria Workers
  • Deep-Cleaning Staff
  • Employees working closer than 6-feet
  • First Responders
  • Onsite Screening Team
  • Receptionists
  • Security Guards
  • Shipping/Receiving Employees

In response to respirator shortages caused by the Covid-19 pandemic, the FDA issued an Emergency Use Authorization (EUA) for importing alternatives to the US NIOSH N95s. For more information on this directive, read the guidance here.
Please Note: Employees should continue to follow their routine policies and procedures for PPE (if any) that they would ordinarily use for their job tasks.

Interesting fact: Prior to Covid-19, there were ample USA N95s available in the marketplace and KN95s and other country’s FFPs were not widely available in the US.

GLOVE GUIDANCE

Gloves made of Latex, Nitrile or Vinyl are appropriate for the following roles:

  • Cafeteria Workers
  • Deep-Cleaning Staff
  • Employees working closer than 6-feet
  • First Responders
  • Onsite Screening Team
  • Respective personnel when recommended by the cleaning/disinfecting product being used.

NOTE: The CDC indicated that gloves do not protect individuals against Covid-19 because the virus does not enter the body through the hands.

HAND SANITIZER

The WHO recommends placing sanitizing hand rub dispensers in prominent places around the workplace. Make sure these dispensers are regularly refilled. Provide and maintain hand sanitizer stations at entry and exit points.
The CDC recommends using Alcohol based hand rub (ABHR) with greater than 60% ethanol or 70% isopropanol. Hand rubs are generally less irritating to hands and are effective in the absence of a sink. For best practices on hand washing with Hand sanitizer, we like this video from Johns Hopkins University.
Important note: Recently, the FDA advised consumers not to use hand sanitizer products manufactured by Eskbiochem due to the potential presence of methanol (wood alcohol), a substance that can be toxic when absorbed through the skin or ingested. To ensure the products you are using are both safe and effective, we recommend using a hand sanitizer made in the USA by an FDA registered facility.

ADDITIONAL PRODUCT LINES

In addition to Hand Sanitizer, Gloves, Facemasks and Respirators, MF Supply now offers a comprehensive offering of PPE & Safety Equipment, including:

Next up, stay tuned for guidance on Disinfectating your workplace.

Stay Safe!
Robin & the MF Supply Team

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