Is there a shortage of gowns? Surgical masks?

The Below Surgical Masks and Gowns Information was found 4-15-20 on the FDA.gov website web page.
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.

Can respirators approved under standards used in other countries, such as KN95, be used in the US during the COVID-19 pandemic?

Yes. The 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 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.

The FDA also issued guidance outlining a policy to help expand the availability of general use face masks for the general public and respirators for health care professionals during this pandemic. The guidance applies to KN95 respirators as well. It explains that for the duration of the pandemic, when FDA-cleared or NIOSH-approved N95 respirators are not available, the FDA generally would not object to the importation and use of respirators without an EUA, including KN95 respirators. Although not required, if a KN95 respirator does not have an EUA, the FDA encourages importers to take the appropriate steps to verify the product’s authenticity prior to importing.

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 is ready and available to engage with importers to minimize disruptions during the importing process.
END FROM FDA
More from the FDA at FDA web page: CLICK HERE

Anthony, President
772-777-2241,
Product Development Experts, Inc.
Please feel free to contact us with your face mask and PPE – Personal Protection Equipment questions.
(Edit)

When you license a product to a product broker or manufacturer they’re going to advertise it, market it, manufacture it and put their money into the project. So you don’t need to raise money or run a company. That’s a pretty big plus, especially for beginners or inventors who are short on capital.

Why license my product, patent, invention or idea?

Another great benefit of licensing is that the manufactures you’ll be contacting already have a network of retailers that they can plug your new product into. If you start a company on your own, not only do you need to raise money to start the company, you have to start from scratch and make new relationships with retailers so you can get your product into their stores.

This can be a problem since most retailers don’t want to deal with one-product companies. Retailers want to deal with companies that have ten, twenty or even hundreds of products. Many retailers don’t take one-product companies seriously and are very concerned that you’ll have enough cash flow to deliver on a consistent basis and on time.

When you license your product, the manufacturer will already have those important relationships with retailers, so all they have to do is plug your product in.

Regarding money or capital
Then of course there’s the money issue. When you start your own company and manufacture a product on your own, you will most likely need hundreds of thousands of dollars to manufacture market and distribute your product even if your product only cost pennies to manufacture. You need big money to market, advertise, distribute, manufacture and pay employees or contractors.

When you license your product to a product broker or manufacturer, they will have financial resources you could never have. Also, they may have ten, twenty or even thirty years experience in the industry of your invention. That’s a good combination, and that’s the power of licensing and teaming up.

With licensing, your licensee invests all their money and takes all the financial risk. If for some reason they don’t perform, you get your invention back and you can then license it to someone else. Licensing means none or less financial risk than when manufacturing and marketing a product on your own.

When you license the product, the investor or manufacturer handles everything that’s required to run the business, so you’ll have the free time to go about your daily life. Hopefully you’ll spend some of that free time working on licensing your second product so you can have a second royalty check coming in.

What’s a common royalty rate?

A common royalty rate for consumer products is quite often 3-10%. Now you may be asking what is that 3-10% of?

It’s 3-10% of the wholesale price, not the retail price. So if a product sells at Wal-Mart for $20 and Wal-Mart buys the product for $10 from the manufacturer, then you would receive 3-10% of $10 for each unit that is sold.
So if you think your product is going to retail for $20 and wholesale for $10, you can calculate your royalty based on the number of units you think the manufacturer can sell each year.

It’s going to be advantageous to license products that can do large volume as opposed to small volume. The beautiful thing about licensing is that a major manufacturer can invest far more money than you ever could in a project and sometimes sell millions of units. These royalties can really add up if you team up with the right manufacturer. So if you have ten ideas and you’re trying to figure out which one to work on. Go with the high volume one rather than the low volume one. More than likely it’ll mean the same about of time invested in closing a deal, but reap much higher financial rewards.

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A message from the president and owner of the company:

I’m here to assist inventors, companies and organizations with their Prototyping needs. I will find you with expert product licensing services and solutions.

Thanks for taking the time to view this product licensing website and I look forward to hearing from you.
Anthony

Product Licensing and Invention Licensing Help Phone 772-934-6014