Medical and Surgical Isolation Gown Manufacturer from U.S.

Education to Choose the Right Reusable Isolation Gowns Wisely

 

Disclaimer: This message is for frivolous lawsuit people. Did you know it is wrong to lie and wrong to do what you do. If you do this, then you are considered a bad person. You can stop now and change who you are. Start your new life today. This gown is designed as a solution to assist medical personnel responding to the COVID-19 pandemic and provides some level of protection. But no isolation gown will not keep you from getting sick. The design and materials make it, according to the FDA, technically a Non-Medical Device Class 1 Non-Surgical isolation gown which is exempt from regulation by the FDA, CDC or any other regulatory body. Use at your own risk. But if you were my mother, and in the medical field, I would insist you wear one of our isolation gowns to help keep the virus off of your skin and clothes and greatly lower your chances of becoming ill.

A Special Note: If you are looking for disposable medical and surgical solation gowns, then you are going directly against the guidelines of the CDC during this time. They have told all health care providers to switch to reusable cloth gowns immediately, which is what we are manufacturing. Our cotton and or cotton/polyester isolation gowns are water resistant and used around the world and exactly what the FDA has told us are good to go to market with. 

Saddleback Leather, is a U.S. company that designs and manufactures the longest lasting most durable cool leather briefcases, backpacks and duffle bags in the world. We're REALLY good at sewing leather. But when we heard our Texas governor's “call to arms”, we changed our leather factory over to being a manufacturer of much needed Personal Protective Equipment (PPE’s), We own our factory in Central Mexico,  Old Mexico Manufacturing, and we love our people. Check out my wife and I explaining our factory in this video here.

Here is a demonstration video of our gown and of its water resistance compared to a Level 2 disposable surgical medical isolation gown material here.

If your neighbor has stickers and weeds in their yard, then you'll probably get them too. If their yard is healthy, yours will be healthier too. So, please consider buying goods made by your neighbors n Canada, the U.S. and Mexico if it is an option. If there were ever a time to lift your neighbor up, that time is now. Your neighbors need the work. And if you support them now then they'll more easily be able to support your company with the goods and services it offers too. 

Last January, China spent billions of dollars buying up all of the PPE’s from around the world and are now price gouging by selling them back at ridiculous prices. Watch is video from CBS about the gowns. The Chinese people are beautiful, but the Communist Chinese government, in my opinion, is not on so many levels. In a month or two, boatloads of very photogenic but cheaply made, thin, low quality, fall apart after a couple of washes, not very protective Chinese isolation gowns will be flooding the US market, along with some quality ones too.  Watch this video of French nurses and their cheap Chinese gowns. Saddleback Leather had a problem about 10 years ago the only time we bought hardware from China that was too soft and fell apart. Their "certified scientific laboratory" report was fake. Check out this other CBS report on Surgical Gowns from China. Never again will we risk buying anything for Saddleback Leather from China. Watch this European Union news story about all of the fake certificate and unprotective PPE they are handling. By the way, good luck suing or trying to get any refund out of China. Resist the urge to chase low price and instant convenience while sacrificing long lasting quality or protection. Buy nice or buy twice and buy from North America to help build our economy back up. And with the estimated 5 million prison slaves in China's Laogai (Reform Through Labor) prisons, there's a good chance that low price came at a high price to others. Watch Al Jazeera's report on the over 1000 Laogai Prisons.

You can buy our gowns here. We have trucks coming up to our Fort Worth, Texas headquarters each week. The next truck is sold out. If you would like to get in queue for the next available truck with 400 pieces or less. For orders over 400 gowns or masks, contact us at ppe@saddlebackleather.com and we'll get right with you with lower prices and shipping rates. I'm not just saying to only buy our PPE. There are a lot of good quality gowns manufacturers out there. I'm just asking that you consider not buying them from China. 

Water Resistant, Water Repellent or None at All 

There are a lot medical isolation gowns to choose from based on what it's intended use is. If you're doing surgery, dealing with Ebola or are dry, not expecting dangerous fluids splashing up on you, the Center for Disease Control and Prevention asks you to think about the situation you'll be in to determine which level of fluid resistance you should choose.

Fluid resistant isolation gown

Kissing on a date: Water Resistant versus Water Repellent? Which isolation gown is right for working with COVID-19 patients?  

Let's say a guy and girl go on a first date and right away the guy tries to kiss her. She is RESISTANT and says, "Listen here Buck-o, I'm not that kind of girl". But they get along really well and before long she gives in and kisses him. If she is REPELLENT then when he tries to kiss her, she REPELS him by kicking him where it counts and shoving her thumb into his eye socket. He runs off and has officially been repelled.Level 1 and 2 non-surgical isolation gowns are supposed to resist by not letting it blast right through the fabric, but eventually give in. Level 3 and 4 Surgical Medical isolation gowns repel the water and it runs off screaming. For COVID-19 workers, the CDC has told them to move to regular isolation gowns like the ones we're manufacturing. And here's why.

An OSHA instructor said that this is a good way to explain it. If you're wearing a tightly woven fabric shirt in a light rain, the drops may soak in and get you wet eventually, but you're not going to feel the raindrops hit your skin directly. Tightly woven Cotton or Polyester fabric is water resistant. If you're wearing an airy loosely woven linen shirt, then you will feel the raindrops hit your skin directly. It's the same with a cloth isolation gown. If someone coughs or sneezes on you, then you don't want to feel it on your skin or have the microbes casually float through one of the gaps in a loose weave. Remember, the goal of the gown is to protect people from getting the virus on their skin and clothing. Don’t get a thin one.

  1. Water resistant cotton/polyester isolation gown - If they are going to stay dry, but don’t want virus droplets getting on their clothes, then they only need a cotton or cotton/polyester isolation gown. If the wearer is going to be exposed to Coronavirus patients or someone with a hurt back, then they don’t need a water repellant gown because the virus microbes are passive and just float around, only moved by air movement. They don’t land on a gown and start burrowing through to the person. 
  2. Water repellant medical isolation gown - If they’re going to be helping someone who ate a dozen bad oysters, then a water repellent medical surgical gown is the one you want. If they might get bodily fluids like blood, puss, vomit, saliva, snot, urine or poop on them, then they’ll need a water repellent Medical gown. No one wants it to soak through their gown and get onto their clothes or skin. 

A hazardous materials expert in our city said their fireman suits are made with a water repellent technical synthetic fabric, but they still have to treat it every 10 washes to keep it water repellent. The normal cotton or cotton/polyester clean isolation gown is used around the world for the purposes like the COVID-19 Coronavirus, are not water repellent, as in, fluids don’t bead up and roll off, because the CDC and FDA don’t require they are. Of course, the typical cotton or cotton/polyester blend is water resistant like jeans are against light mists and light rain. The Indiolino cotton fabric technical specs.The benefits of reusable medical isolation gowns over disposable.

  1. For your emergency disaster reserve. Because of the switch to disposable from washable reusable isolation gowns, very few have an emergency reserve in the U.S. 
  2. Disposable Gowns have a horrible shelf life. Use them fast because they fall apart and are worthless in a short time. They're an inventory nightmare to store.
  3. Cloth isolation gowns are long-lasting. The COVID-19 is not going away anytime soon. The CDC even recommends in times like this that if you get a tear in them, to patch it.
  4. Less expensive to own. A study by Enviironmental Clarity Inc. found reusable isolation gowns reduce costs as much as 25 to 50 percent. Buy 60 disposables or 1 reusable. 
  5. More efficient employees. Hospitals who committed to reusables earlier are not short on supplies and their employees are working on important matters instead of searching for next month's supply.
  6. Environmentally Great. Disposable medical gowns do not decompose in landfills. Some incredible Spunbound Polypropylene disposable trash isolation gowns salesman sold healthcare providers to throw away stadiums full of isolation gowns into landfills yearly. Only a few VERY wealthy people will ever know how that happened. 
    1. 30% lower greenhouse gas emissions
    2. 28% lower consumption of natural resource 
    3. 41% lower water consumed that is not returned to the source
    4. 93% to 99% lower solid waste at healthcare facilities
  7. Everybody's doing it. Europe and most of the rest of the world primarily uses biodegradable cotton, cotton/polyester or polyester gowns like ours.

The urgency to manufacture reusable medical isolation gowns:

  1. Health care workers are refusing to come to work if there are no PPE’s to protect them, for fear of infecting and killing themselves or their families. One hospital I heard of ordered 100,000 shower curtains for their staff. Medical staff are disgracefully wearing plastic trash bags.
  2. The supply chain is not going to be normal for quite awhile. One dentist said that he'd wear a tent if there were one available.
  3. An estimated 100 million Americans will be infected. There are about 7.6 million front line medical workers who need gowns for each of those encounters.
  4. October 2020 thru March 2021 will have influenza AND COVID together. There will be even more demand.

 

For more information on pricing and availability and deliveries, please email ppe@saddlebackleather.com

In their wisdom, The Center for Disease Control and Prevention (CDC) knew that if all we have are disposable isolation gowns and our supply chain were cut off, like it is now, it would be disastrous. And they were right. Therefore, the CDC gave all health care and government agencies the following strategies to execute on during “Contingency” and “Crisis Capacities”.

Concerning isolation gowns in the Contingency Capacity (we are beyond that and in the Crisis Capacity), the CDC tells all health care providers to “Selectively cancel elective and non-urgent procedures and appointments for which a gown is typically used by HCP”. Then, Shift gown use towards cloth isolation gowns. Reusable (i.e., washable) gowns are typically made of polyester or polyester-cotton fabrics. Gowns made of these fabrics can be safely laundered according to routine procedures and reused.”  And this is why we’re manufacturing PPE’s exactly like the ones The CDC, FDA and The National Institute of Health suggest everyone use.

Our Reusable Cloth Face Masks are the exact washable cloth mask that the CDC has on their website that they recommend for the general public to wear. They are not as good as the medical N95 or surgical masks, but they are double layered cotton and good for stopping a lot of the transmission of the Coronavirus. An ER doctor just told me that they use homemade masks like this over the top of their really good masks so they don’t go through the good ones so quickly. He said it’s easier to wash a cloth one than find a medical one. But again, the CDC says that this will not keep you from getting sick, but it will help others to not get sick by you.

How to Wash if you don’t have facilities? There are a few options for washing I've been thinking of for interim solutions. There is a valid fear of the virus floating off of the gowns and getting laundry personnel sick. If they were shaken outside in the wind or in front of a big fan before they were picked up from the hospital and also dampened before they were picked up, then that would help ease the fear of the virus getting loose. 

  • Hotels can contribute by laundering in their facilities since they aren't laundering all of those towels and sheets each day. They are set up for huge amounts of laundry. 
  • Employees assigned gowns and responsible to launder them. 
  • Ask the public to help. To pick them up at the hospital and return them laundered. 
  • Give people a whole lot of rolls of quarters to go to 24 hour laundromats.
  • Contract with laundering services.

Learn the basics of fabric so you don’t get took with a cheap loosely woven fabric. One square yard of our fabric weighs 5.2 oz. therefore it is 5.2 oz fabric or 175 grams per sq. meter. It's a tightly woven material developed to resist water. Be careful if someone offers you a reusable isolation gown that is a lesser weight fabric than that. It generally means that the fabric is not as tightly woven (or doesn't have as many threads per square inch and therefore has a whole lot more little gaps between the threads. And remember, some of the fibers of the thread fall off with each wash and dry cycle to make it even less protective. Every inch of our fabric has 62 threads going longways (warp) and 40 threads going left to right (weft). That's why it weighs so much. Saddleback Leather's Scottish canvas bags are made with a 24 oz cotton fabric. To learn more why canvas is a far superior reusable material to nylon or others, check out here why natural cotton canvas tents, like our gowns, are the best for camping in wet weather.

Level 1, 2, 3 or 4 Isolation Gown to use

 

In this article from the National Center for Biotechnology Information (NCBI) and the National Institute of Health (NIH), they talk about the accepted and current use of reusable cotton isolation gowns throughout all of Europe and the rest of the world. 

The hospitals in other countries and the ones who already using reusable cloth isolation gowns in the USA, aren't desperate right now because they just wash theirs and use them again. Why wouldn’t the Federal Government have a giant reserve in the Strategic National Stockpiles of cotton or polyester/cotton isolation gowns like the CDC insists needs to happen in emergencies? It seems that you’d want to have medical equipment that has a long shelf life instead of the short shelf life disposable Spunbound Polypropylene trash.

 

Indiolino technical information for isolation gown

isolation gown specifications reusable cotton

We reached out to the FDA to register to be under their regulations and their response is that it was unnecessary because gowns like ours are not regulated by the FDA. Their email is below.

 

 

Details of our Isolation Gowns:

  • Material: Cotton
  • Sizes: One size fits all
  • Reusable: Washable. Some wash them up to 70 times.
  • Capacity: 100,000 per week
  • Country of Origin: Mexico
  • Timeline for Delivery: Approximately 3 weeks from the time a deposit is made. We can begin production immediately upon securing a deposit and the raw materials. Shipments will be made each week to our warehouse in Fort Worth, Texas. For orders over 50,000 pieces, we can also ship directly from our  or directly to one location in the lower 48 states except for Alaska or Hawaii. To those states, it will cost you more to ship from Fort Worth, Texas. Air freight can be found through several of the direct flights into the BJX airport for more urgent needs or for Hawaii and Alaska.
  • Registrations: Old Mexico Manufacturing is registered with the U.S. Department of Homeland Security in their CTPAT program. It is also registered with the Mexican government’s program IMMEX as a Maquiladora (foreign owned factory for the purpose of exporting out of Mexico).
  • Old Mexico Manufacturing: Our factory has been manufacturing in the same place since 2008, manufacturing for Saddleback Leather as well as for several other American companies. We have 250 employees.

The following is from the CDC’s website

https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/isolation-gowns.html

 

Strategies for Optimizing the Supply of Isolation Gowns

Crisis Capacity Strategies

Cancel all elective and non-urgent procedures and appointments for which a gown is typically used by HCP.

Extended use of isolation gowns.
Consideration can be made to extend the use of isolation gowns (disposable or cloth) such that the same gown is worn by the same HCP when interacting with more than one patient known to be infected with the same infectious disease when these patients housed in the same location (i.e., COVID-19 patients residing in an isolation cohort). This can be considered only if there are no additional co-infectious diagnoses transmitted by contact (such as Clostridioides difficile) among patients. If the gown becomes visibly soiled, it must be removed and discarded as per usual practices.

Re-use of cloth isolation gowns.
Disposable gowns are not typically amenable to being doffed and re-used because the ties and fasteners typically break during doffing. Cloth isolation gowns could potentially be untied and retied and could be considered for re-use without laundering in between.

In a situation where the gown is being used as part of standard precautions to protect HCP from a splash, the risk of re-using a non-visibly soiled cloth isolation gown may be lower. However, for care of patients with suspected or confirmed COVID-19, HCP risk from re-use of cloth isolation gowns without laundering among (1) single HCP caring for multiple patients using one gown or (2) among multiple HCP sharing one gown is unclear. The goal of this strategy is to minimize exposures to HCP and not necessarily prevent transmission between patients. Any gown that becomes visibly soiled during patient care should be disposed of and cleaned.

Prioritize gowns.
Gowns should be prioritized for the following activities:

  • During care activities where splashes and sprays are anticipated, which typically includes aerosol-generating procedures
  • During the following high-contact patient care activities that provide opportunities for transfer of pathogens to the hands and clothing of healthcare providers, such as:
    • Dressing, bathing/showering, transferring, providing hygiene, changing linens, changing briefs or assisting with toileting, device care or use, wound care

Surgical gowns should be prioritized for surgical and other sterile procedures. Facilities may consider suspending the use of gowns for endemic multidrug-resistant organisms (e.g., MRSA, VRE, ESBL-producing organisms).

For more information on pricing and availability and deliveries, please email ppe@saddlebackleather.com

Tech Drawings and Photos

The following drawings we made are of the isolation gown we are proposing and the pictures that follow are pictures of the actual prototypes that we produced at our factory in Mexico. I received them at our warehouse in Fort Worth, Texas March 30th, 2020. The people in the pictures are 5’3”, 5’10” and 6’2”.


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For more information on pricing and availability and deliveries, please email ppe@saddlebackleather.com
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