​​​​​​​Isolation Gowns – US warehouse inventory + NEWS

GREENandSAVE Staff

Posted on Wednesday 15th July 2020
isolation gown

Isolation Gowns – US warehouse inventory + NEWS

For COVID-19, Personal Protection Equipment (PPE) is key to prevent the additional spreading, especially in states that are seeing surges in cases among young people. Available low cost US inventory of PPE in American warehouses is an advantage for volume buyers who seek to use the PPE or resell it.

The increase of COVID-19 in many US states continues to plague America as the rest of the world watches the troubles that we face. Louisiana based PPE Source International has the experience and the ability to help end users, distributors, and resellers with Isolation Gown and Nitrile Glove inventory as well as IR forehead thermometersKN95 Medical Masks, and other PPE, including, civilian KN95 masks, and gel hand sanitizer in a range of sizes.

To order contact: Sales@PPESourceInternational.com

Click here for more Personal Protection Equipment and also click here for ultraviolet disinfection technology that includes options for HVAC duct integration, in room devices and portable UVC disinfection devices.

GREENandSAVE welcomes the opportunity to provide updates to our readers on how your company is assisting in the efforts to reduce the spread of COVID-19.  Please Contact Us.

NEWS on COVID-19 is always helpful to stay up on the situation. Here is a sample:

https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/faqs-shortages-surgical-masks-and-gowns-during-covid-19-pandemic

Q: Is there a shortage of gowns? Surgical masks?

A: The FDA is aware that as the COVID-19 outbreak continues to expand globally, the supply chain for these devices will continue to be stressed if demand exceeds available supplies. We have received information from healthcare organizations that some distributors may have placed certain types of personal protective equipment (PPE) on allocation, basing the quantity available to the healthcare organization on previous usage, not projected use. Increased use may exceed the available supply of PPE, resulting in shortages at some healthcare organizations.

The FDA recommends conservation strategies for use by healthcare organizations and personnel—categorized for a range of clinical needs and supply levels—intended to assist healthcare organizations in determining conservation procedures during this time period. The FDA's recommendations are intended to augment, and not intended to replace, specific controls and procedures developed by health care organizations, the Centers for Disease Control and Prevention (CDC), or CDC's Healthcare Infection Control Practices Advisory Committee (HICPAC) to aid in infection prevention and control.

Q: Can respirators approved under standards used in other countries, such as KN95, be used in the U.S. during the COVID-19 pandemic?

A: Yes, under an emergency use authorization. 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.

Importing Non-NIOSH-approved N95 Respirators

Non-NIOSH-approved N95 respirators made in China

  • 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, the FDA revised and reissued the April 3, 2020 EUA based in part on concerns raised about the performance 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 some respirators failed to meet the expected filtration performance efficiency.
  • On June 6, 2020, the FDA reissued the Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China by revising the Scope of Authorization such that authorized respirators listed in Appendix A will no longer be authorized if decontaminated. The FDA also reissued multiple decontamination system EUAs, such that, among other things, they are no longer authorized to decontaminate respirators manufactured in China, where applicable.

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 (for example, 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.

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)

test image for this block