In response to the PPE shortage created by the COVID-19 pandemic, InsulFab engineers have developed an innovative new face shield that has gained wide acceptance at major hospitals in the U.S. and Canada.
A call from 3M prompted InsulFab to quickly mobilize its engineering team to devise an optically clear, 10 mil face shield that can quickly and efficiently protect healthcare workers on the front lines of the pandemic, including doctors, nurses, first responders, COVID-19 testers and others who may be in close contact with potentially ill people.
The idea behind the design was to not only provide more facial coverage than traditional face shields, but to also deliver a solution that laid flat, making it easier to ship in bulk and distribute on demand. Face shields have traditionally been reserved for surgeons in the operating theater, but now they are needed by more healthcare personnel than ever before, requiring a solution that is lightweight, comfortable and adjustable.
Additionally, the InsulFab face shield was designed to meet the existing ANSI / ISEA Z87.1 standard for fluid transmission. Other standards, including FDA, OSHA, NIH, NIOSH and CDC recommendations have been addressed, so that health professionals can literally "check the boxes" for compliance when purchasing.
Of course, the most important consideration is performance, and unlike the thinner 5 and 7 mil thick plastic shields that are currently being rushed to market by others, InsulFab's Face Shield is heavy duty, durable and designed for the harsh conditions of the medical industry.
Check out the resources in this InsulFab Face Shield Product Spotlight to learn more about the InsulFab Face Shield.
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- InsulFab Face Shield is a full 9" long x 15" wide, covering more of the face
- Soft skin-friendly foam spacer ensures maximum comfort
- Adjustable loop strap keeps the shield situated firmly in place
- Meets ANSI Z87.1 - 2015 Standard
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InsulFab Unveils its Novel Design on YouTube
InsulFab's Face Shield was first introduced in a professionally- produced video for YouTube.
The best way to highlight the product, other than by sampling, is to see its form, fit and function on real people. After getting fee
dback from several surgeons who tried it out, InsulFab engineers made two important adjustments.
First, a face shield should always extend "below the mandible." Although the original design extended 7-1/2 inches from the forehead below the chin, the trial revealed that wasn't enough. Working together, InsulFab and the doctors agreed that a full 9 inch drop was best. Physicians can always trim the shield with scissors, but if the face shield is too short, it may not be effective. InsulFab has seen other face shield models as short as 7 inches long.
Second, the trial indicated that more of the face needed coverage. Face shields often taper to the forehead, leaving sides of the face exposed. The InsulFab Face Shield extends behind the ears covering the entire face from aerosol, fluid and face-touch transmission.
While these key design features may deviate slightly from traditional designs, the COVID-19 virus is believed to be highly transmittable mostly by contact with the face.
A copy of the link to the YouTube Video can be found below, or by simply going to Youtube and typing "InsulFab Face Shield" into the search bar.
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Technical Data Sheet
The InsulFab Face Shield Technical Data Sheet has comprehensive product information on the front side, and more technical information about industry standards, specifications and compliance on the reverse side. It should be your first and best resource to get your questions answered quickly!
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Is InsulFab Face Shield Registered with the FDA?
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By far, this is the number one question asked. The answer is that the face shield itself does not need to be registered with the FDA. InsulFab, as a company is currently registered with the FDA.
Face Shields are considered a Class I medical device, the lowest risk of the three FDA Classifications. It is technically regarded as
“surgical apparel.”
Class I medical devices are exempt from Pre-Market Notification (Form 510[K]), but are subject to the the FDA’s Quality System Regulation and a myriad of other regulatory requirements.
Although the FDA does not require Pre-Market Notification, manufacturers of Class I medical devices are required to register with the FDA and comply with its regulatory framework, which can be complex. The FDA can then monitor the manufacturer's compliance through periodic inspections and take enforcement actions (including warning letters, injunctions, seizure, civil monetary penalties) as necessary. So, for example, if there is a complaint filed about a face shield, the FDA is able to locate and enforce compliance on the manufacturer, who has registered and agreed to subject itself to their authority.
Manufacturer registration is required in spite of the end use of the face shield. If a face shield serves a medical purpose, the FDA has enforcement responsibility. Registering with the FDA requires an annual fee of approximately $5,200, the filing of a number of forms and disclosures as well as the maintenance of a quality and reporting system capable of meeting the FDA's requirements.
During the current public health emergency, the FDA has relaxed some of the registration and compliance requirements in order to create a broader market for face shield PPE. However, this measure is temporary, and the five page guidance letter is by no means a waiver of all requirements. Some companies may review and comply with the FDA's guidance letter, more than likely some won't. In fact, some of them may have no intention of registering when the FDA reimposes requirements.
As a result, it will be up to the purchaser to determine whether they wish to purchase from a company not registered with the FDA, and determine whether that company is the best long term solution to provide valuable PPE which is worn on the faces of its doctors, nurses and may be used in its operating and examination rooms.
For futher review, a copy of the FDA's April 13, 2020 letter can be found below.
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ANSI / ISEA Z87.1: 2015
The ANSI Z87.1:2015 American National Standard helps eliminate eye and face hazards in occupational settings. It has a number of variations, but the primary test for fluid is ANSI Z87.1 D3.
ANSI/ISEA Z87.1:2015 is the generally-recognized standard for face shields. It should be noted, however, that the ANSI Z87.1 does not address certain hazardous exposures like bloodborne pathogens, X-rays, high-energy particulate radiation, microwaves, radio-frequency or lasers. There is no universal standard for determining how a face shield can protect against a virus. A more in-depth article discussing the standards for facial protection against viruses can be found here:
Face shields for infection control: A review.
The InsulFab Face Shield Standards, Specifications and Guidance information can be found on the reverse side of the Technical Data Sheet, and includes guidance as to OSHA, FDA, CDC and NIOSH. Although those agencies may not set standards for compliance, their input should be considered.
InsulFab's ANSI Z87.1D3 lab results are available upon request.
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Buyer's Checklist
With the number of face shield manufacturers growing, it is important to understand some key differences between suppliers and their products. Due to the current public health crisis, most of the inquires from hospitals are based primarily on availability and lead time. Price may be an issue, but a secondary one.
However, in order to be an educated buyer, we have developed a buyer's check list, to ensure that decisions are made efficiently, but also with diligence and common sense.
Often, manufacturers may require relatively high minimums, and the chance of a healthcare facility being stuck with a large quantity of face shields is high, so it is important to make sure that the face shield and the supplier it comes from are vetted for the basic requirements. Wherever hospitals purchase from, they should always consider these questions.
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How Do I Order Place my Order?
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Ordering is easy. There are three ways to contact us.
You can also call us directly at (214) 956-0055, or Toll Free (800) 442-1338, and follow the prompt for "face shields." That will bypass the operator and connect you directly with a Customer Service team member ready to assist you.
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If it's after hours or your prefer email, just email our Customer Service email faceshields@insulfab.net. The email address is constantly monitored by a team dedicated to quick response.
If you have other questions, we have posted a list of Frequently Asked Questions below.
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InsulFab Face Shield Production in the Media
InsulFab's ability to run hundreds of thousands of shields, at rates of up to 60,000 per week, caught the attention of several televisions news outlets and drew the praise of Texas Governor Greg Abbott, who specifically mentioned InsulFab while thanking Texas businesses that demonstrated a commitment to serving their community.
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“Coppell Company Pivots Production To Make Medical Faceshields,” Noelle Walker, local DFW NBC affiliate, NBC 5
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“Protection, Prayers, PPE Offered,” Kevin Reece, local DFW ABC affiliate, WFAA
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“Ole Miss Alum Uses Company To Make Face Shields for Hospitals,” Allie Ward, local Jackson, MS ABC affiliate, WAPT
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“Texans Are Saving Lives,” Texas Governor Greg Abbott’s opinion article to the Dallas Morning News
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Sanitary Production and Packaging
Not enough can be said about the need for sanitary best practices from production all the way to pack out.
InsulFab ensures that material is transported in sanitary totes to its two clean rooms for assembly. No assembler is permitted in the sanitary assembly and packaging room without having their temperature recorded and monitored before entry and wearing appropriate PPE. The assemblers pack out 50 face shields in each box before sealing the box with tamper-resistant tape.
This controlled process not only ensures that the material is not inadvertently cross-contaminated by Insul-Fab's production personnel, but also that the package is not capable of being opened and repackaged before it reaches its final destination at a healthcare facility.
Even the experts are not unanimous on how long the virus can live on various surfaces, and no face shield manufacturer should take any chances with the health and welfare of hospital and health care workers.
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Soft, skin-friendly non-woven covering over foam for comfortable contact
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Fully assembled sheets lie flat, neatly laid out in quantities of 10 per bag
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Boxes are uniformly packed out in quantities of 50, weighing only 6.5 pounds
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The 3M Company and FedEx have graciously offered to partner with InsulFab
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Giving Back to Communities that Need it Most
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Joseph ("Jody") Rigby, 34 years as a first responder, President of First Responders of Mississippi
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InsulFab's goal is simple: a sustainable, long-term supply of low cost face shields to hundreds of thousands of health care workers and first responders. While InsulFab could have donated face shields for free to a few thousand, it has chosen to make a broader impact by helping hundreds of thousands in the health care community.
That said, InsulFab is helping organizations that need it most for free. The First Responders of Mississippi was one of those. A 501(c)(3) dedicated to donating supplies to first responders, we heard their story and knew we had to help. The full story can be found at the link just to the left. But we were happy to help several hundred first responders in that state with ready-to-deploy face shields.
Please see our Facebook Page (below) for more updates about our donations!
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Get a Free Sample
InsulFab offers prospective purchasers the opportunity to sample the InsulFab Face Shield for free.
Email the Customer Service Team at faceshields@insulfab.net to have an InsulFab Face Shield overnighted anywhere in the US or Canada. And thanks to our partner, Fedex, for helping us to be able to provide quick turn samples, so that hospitals can have peace of mind that the InsulFab Face Shield is the right solution.
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Our other key partner, 3M, also assists with the materials that makeup our InsulFab Design.
As a select converter for 3M, InsulFab has access to a full line of foam tapes and adhesives. Of course, 3M also offers its own line of medical PPE to assist with the current public health crisis, and InsulFab can put you in touch with the right people to help!
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We're on Social Media: Facebook and LinkedIn
Great information and updates are posted to our Social Media accounts regularly. Please type "Concote Corporation" in the search bar on Facebook or LinkedIn and you can see photos, read updates and find out how to easily contact us. You may also simply click one of the icons or headers below to go straight there!
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