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Having Personal Protection Equipment (PPE) in US warehouses is a huge advantage for volume buyers. PPE Source International has the experience and the focus to help end users, distributors, and resellers with KN95 Medical Masks, and other PPE, including gel hand sanitizer, IR forehead thermometers, and civilian KN95 masks.
If you would like GREENandSAVE to provide updates to our readers on how your company is assisting in the efforts tor reduce the spread of COVID-19, please Contact Us.
Q: Can respirators approved under standards used in other countries, such as KN95, be used in the US during the COVID-19 pandemic?
A: Yes. The U.S. Food and Drug Administration (FDA) is working diligently to mitigate any potential shortages in the supply chain and taking action to assure health care personnel on the front lines have sufficient supplies of respiratory protective devices. The FDA concluded, based on the totality of scientific evidence available, that certain imported respirators that are not National Institute for Occupational Safety and Health (NIOSH)-approved are appropriate to protect the public health or safety.
On March 24, 2020, the FDA issued an Emergency Use Authorization (EUA) for importing non-NIOSH-approved N95 respirators. Under this EUA, among other criteria, the FDA accepts marketing authorization from Australia, Brazil, Europe, Japan, Korea, and Mexico who have similar standards to NIOSH. The FDA did not list KN95 respirators in this EUA because of concerns about fraudulent products listed as KN95s. On April 3, 2020, in response to continued respirator shortages, the FDA issued a new EUA for non-NIOSH-approved N95 respirators made in China, which makes KN95 respirators eligible for authorization if certain criteria are met, including evidence demonstrating that the respirator meets certain standards. On May 7, 2020, FDA revised and reissued the April 3, 2020 EUA based generally on concerns raised about the authenticity of certain respirators authorized under the third criterion of the April 3, 2020 EUA. For example, data from NIOSH testing on some respirators that were listed in Appendix A showed that the respirators failed to meet the expected filtration performance efficiency.
The FDA also issued guidance outlining a policy to help expand the availability of general use face masks during this pandemic. Face masks may also be authorized for use as source control (i.e. not as PPE) under the Face Mask umbrella EUA if certain criteria are met.
The FDA has adjusted its import screening to further expedite imports of legitimate products and is continually monitoring its import systems to prevent and mitigate any potential issues. The FDA established a special email inbox, COVID19FDAIMPORTINQUIRIES@fda.hhs.gov, for industry representatives to quickly communicate with the agency and address questions or concerns. The FDA is ready and available to engage with importers to minimize disruptions during the importing process.
The FDA recognizes that the need by health care personnel for personal protective equipment (PPE) such as surgical masks and surgical and isolation gowns, may outpace the supply during the Coronavirus Disease 2019 (COVID-19) outbreak.
The FDA is collaborating with manufacturers of personal protective equipment (PPE) to help facilitate mitigation strategies related to the COVID-19 outbreak. The FDA's door is open, and we are available to collaborate with stakeholders.
To help alleviate supply pressures, the FDA may consider expedited review of manufacturing site changes or premarket submissions—manufacturers of PPE (particularly surgical masks and surgical or isolation gowns) may contact FDA regarding plans to increase availability of these products to the U.S. market.
For reference, the applicable product codes discussed in these FAQs are:
- Surgical masks (FXX)
- Surgical mask with antimicrobial/antiviral agent (OUK)
- Pediatric/child facemask (OXZ)
- Surgical gowns (FYA)
- Isolation gowns and surgical apparel accessories (FYC, LYU, OEA)
- Surgical suits (FXO)
The FDA is interested in hearing from manufacturers who may be able to help mitigate potential shortages of the above product codes by increasing U.S. availability of such devices. These manufacturers may email the FDA at deviceshortages@fda.hhs.gov. This closely monitored email account has proven to be a valuable resource to help the FDA mitigate potential supply chain disruptions.
To facilitate a rapid response to your email, please see an example of information the FDA would find helpful to have initially:
Subject of the email: "Product Codes XXX, Shortage Mitigation Options for FDA Engagement," where XXX represents the product code(s).
Body of the email:
- Describe the affected product or products which may include the brand name, model number, 510(k) number, etc.
- Describe the proposed mitigation approach.
- Identify what you are interested in discussing with FDA, such as:
- Expedited review of a premarket submission, or
- Expedited review of a manufacturing site change if you are a class III device manufacturer, or
- Information about importing certain products.
Q: How can manufacturers of personal protective equipment (PPE) who may be considering increasing availability of these products to the US market engage with the FDA?
A: The FDA recognizes that the need by healthcare providers and personnel for personal protective equipment (PPE) such as surgical masks and surgical and isolation gowns, may outpace the supply during the Coronavirus Disease 2019 (COVID-19) outbreak.
The FDA is collaborating with manufacturers of personal protective equipment (PPE) to help facilitate mitigation strategies related to the COVID-19 outbreak. The FDA's door is open, and we are available to collaborate with stakeholders.
To help alleviate supply pressures, the FDA may consider expedited review of manufacturing site changes or premarket submissions—manufacturers of PPE (particularly surgical masks and surgical or isolation gowns) may contact FDA regarding plans to increase availability of these products to the U.S. market.
For reference, the applicable product codes discussed in these FAQs are:
- Surgical masks (FXX)
- Surgical mask with antimicrobial/antiviral agent (OUK)
- Pediatric/child facemask (OXZ)
- Surgical gowns (FYA)
- Isolation gowns and surgical apparel accessories (FYC, LYU, OEA)
- Surgical suits (FXO)
FDA is interested in hearing from manufacturers who may be able to help mitigate potential shortages of the above product codes by increasing U.S. availability of such devices. These manufacturers may email FDA at deviceshortages@fda.hhs.gov, which is closely monitored and has proven to be a valuable resource thus far in helping FDA mitigate potential supply chain disruptions.
To facilitate a rapid response to your email, please see an example of information that FDA would find helpful to have initially below:
Subject of the email: "Product Codes XXX, Shortage Mitigation Options for FDA Engagement," where XXX represents the product code(s).
Body of the email:
- Describe the affected product or products which may include the brand name, model number, 510(k) number, etc.
- Describe the proposed mitigation approach.
- Identify what you are interested in discussing with FDA, such as:
- Expedited review of a premarket submission, or
- Expedited review of a manufacturing site change if you are a class III device manufacturer, or
- Information about importing certain products.
Q: Which gowns are FDA-cleared? Which surgical masks are FDA-cleared?
A: To identify FDA-cleared products, search the 510(k) Premarket Notification database using the product codes for gowns (FYA, FYB, FYC) and surgical masks (FXX, OUK, OXZ).
Q: Do gowns and surgical mask provide protection from coronavirus?
A: Gowns and surgical masks are intended to provide broad barrier protection. Please see current guidelines from the Centers for Disease Control and Prevention (CDC) on recommended use of PPE during the COVID-19 outbreak. At this time, FDA has not cleared, approved, or authorized any gowns or surgical masks for specific protection or prevention against the virus that causes COVID-19.
Q: Can we use expired gowns and surgical masks? Do they offer the protection needed?
A: These products were designed to serve as protective barriers and thus FDA believes they may still offer some protection even when they are used beyond the manufacturer's designated shelf life or expiration date. The user should visibly inspect the product prior to use and if there are concerns (such as degraded materials or visible tears) the product should be discarded. As a conventional capacity strategy, expired products may be used for training and demonstration purposes where barrier protection is not needed.
Q: Can I reuse a cloth gown?
A: Yes. Cloth gowns that will not be used in a sterile field, such as surgery, can be reused if they are laundered in enzymatic detergent or per the hospital's SOP.
Q: How can I know in advance that manufacturers will have a shortage of masks and gowns so I can prepare?
A: If you are a part of a group purchasing organization (GPO), you may want to contact the GPO staff to determine what communication they receive from their suppliers; otherwise, you can contact manufacturers directly.
Q: My health care organization already has a plan for protection against COVID-19, which includes other types of protective equipment (such as Powered Air Purifying Respirators (PAPRS) or Controlled Air Purifying Respirators (CAPRS)) and other strategies. Are we required to follow the FDA's recommendations listed in the letter to health care providers?
A: The letter to health care providers is intended to aid in the management of gowns and surgical masks. The FDA's recommendations in the letter should supplement a health care organization's policy.
Q:. How do I know what the manufacturer-designated shelf life is?
A: The manufacturer-designated shelf life may be found in the product labeling and if not, you can contact the manufacturer directly.
