ReadyMax® Receives FDA Medical Device Initial Importer Registration For PPE Products

ReadyMax®, Inc., a manufacturer and distributor of medical, hearing and vision PPE products, receives FDA registration to import medical devices.

SPARKS, NEVADA, USA, July 22, 2020 / — ReadyMax®, Inc. has received an FDA Medical Device Initial Importer registration for various personal protective equipment (“PPE”) products, including medical and surgical facemasks, face shields, surgical gowns, infrared thermometers, sterile gloves and other medical devices. The FDA registration allows ReadyMax® to import medical devices from foreign-based factories registered with the FDA. ReadyMax® is a developer, manufacturer and distributor of various PPE products including medical, hearing and
vision devices and holds numerous international patents on products it has developed. ReadyMax® sells its products through US and international wholesale distributors and direct to government, hospital and institutional buyers.

Commenting on the new registration, ReadyMax® Sales and Marketing VP Chris Jelinek said, “We are very pleased to have received the FDA registration which allows us to expand our medical device product offering. Our broad range of PPE products provide head-to-toe protection in many applications including medical, commercial and industrial environments”.
ReadyMax®, Inc. is a Sparks, Nevada-based developer, manufacturer, and distributor of Personal Protective Equipment. The company’s products include medical devices, and hearing, and vision protection, including its patented SoundShield® safety glasses with built-in retractable hearing
protection. The company holds numerous international utility patents on products that protect workers in medical, construction, industrial and recreational activities.

James Duffy
ReadyMax®, Inc.
+1 775-473-9912
email us here

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Everyday Essentials

How to Choose the Right Face Mask

To help prevent the spread of COVID-19, the CDC (Centers for Disease Control and Prevention), in addition to hygiene and social distancing, now recommends the wearing of a mask in public.  This post will focus on the types of masks available.  

Face masks come in an assortment of styles, there are three general types of masks:

Cloth masks

Surgical Masks (aka 3-Ply Masks)

Respirator Masks (N95, KN95, FFP2, and other designations)

Cloth masks can be made at home or purchased from a wide assortment of vendors.  They can help lower the spread of disease from asymptomatic carriers.  That means you.  Cloth masks will help prevent you from spreading viruses to other people, they are not effective at preventing the spread of viruses to you.  The masks should be cleaned after every use.  Care should be taken when removing the masks to not touch you nose mouth or eyes.  Please remember to wash you hands after removing the masks.  

Surgical masks are disposable masks that come in a variety of different styles and grades.  They are designed to cover your nose, mouth, and chin.  A typical mask is a flat rectangle with folds, a metal strip across the top, and elastic bands to either loop behind the ears or head.  The folds allow for the mask to comfortably expand from your nose over your chin. The metal strip is designed to form a better over the bridge of your nose.  Surgical masks that are U.S. Food and Drug Administration (FDA) cleared conform among other things with synthetic blood fluid resistance, bacterial filtration efficiency (BFE) and flame resistance.   Listed BFE ratings typically are from 90% to 98%.  Masks may be non-Sterile or Sterile depending on the intended usage.  In addition to fluid resistance, surgical masks provide the wearer with protection against large droplets, splashes, or sprays of bodily or other hazardous fluids.  The masks also help prevent the wearer from spreading infection to others.  Due to the loose-fitting nature of the masks, they do not provide the wearer from protection from inhaling smaller airborne particles.  

Respirator Masks most frequently known as N95 Respirators or N95 Masks.  N95 represents the testing and certification issued by the National Institute of Occupational Safety and Health (NIOSH).  This respirator is designed to filter 95% of particles greater than .3 microns, including viruses and bacteria.  (Other countries test and certify masks with similar standards.  During the current Corona Virus emergency, the FDA has issued several Emergency Use Authorizations (EUA) allowing the usage of imported masks for medical needs. These designated masks include China KN95, EU FFP2, AS/NZ P2, Korea First Class and Japan DS FFR).  

Surgical N95 Respirators also are cleared by the FDA.  The difference between the two types of N95 Respirators is the fluid resistance required by the FDA.  N95 Respirators come in a variety of styles some with valves and some without.  Those with valves are not cleared by the FDA for use as surgical masks.  They will protect the user; they do not protect others from the user.  Also, there are higher ratings, these include N99 which block 99% of particles, and N100 which block 99.97% of particles.  The most important feature of all N95 Respirators is that a tight fit is required to ensure proper level of protection.  Each time a respirator is used the user should ensure a proper seal is created with the mask.  It should be noted that beards and stubble can prevent the creation of a tight seal.  If the Respirators are used in areas of high exposure, they should be discarded after each use.  They should also be discarded if they no longer form effective seals, if the become dirty or wet, and if they are difficult to breathe through.  

One other important note.  Unless specifically certified, none of these masks provide protection from solids or aerosols that contain oil.  Oil certified masks are designated with an R or a P.  The R designation indicates resistance to oil.  The P designation indicates oil proof.  As an example, a P95 mask is one that is oil proof and filters at the 95% level.  

Keep yourself safe and others safe.  Wear a mask.

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Foreign Object Debris Introduction

Foreign object debris (F.O.D.) is any object, material or substance in a place that it is not supposed to be creating a condition that can cause damage to individuals or equipment.  Foreign Object Damage (also FOD) is the damage caused by Foreign Object Debris.  While the term ‘FOD’ is most closely associated with the Aerospace industry, it also is present in construction, electronics, environmental, manufacturing and transportation.  From the FAA “As defined in AC 150/5210-24, Foreign Object Debris (FOD) Management, FOD is any object, live or not, located in an inappropriate location in the airport environment that has the capacity to injure airport or air carrier personnel and damage aircraft.”

Types of FOD

We’ve all seen litter on the freeway.  Whether a bag, piece of tire or bottle, it all can cause damage or accidents and it all is FOD.  If you have watched a NASCAR race, you’ve seen the tremendous effort by the cleanup crews to remove both debris and liquids from the track.  That FOD can cause even more accidents. In defining FOD the National Traffic Safety Board includes tools, rags, gloves, parts, pieces of broken equipment, paint chips, metal shavings, birds, and consumer products.  Whether it is being ingested in to an engine, cutting a fuel tank, or blowing out a tire, items out of place can create a serious and potentially deadly situation.
foreign object debris search
Foreign Object Debris search on a US Navy Ship
The sources of FOD include personnel, the environment, airport infrastructure, support equipment, airplane parts, and other debris.

Effects of FOD

A tragic incident is the case of Air France 4590.  While departing Charles de Gaulle International Airport the Concorde ran over a piece of titanium debris from a recently departed Continental DC-10, shredding a tire and slamming rubber debris into the plane’s fuel tank. The subsequent leak and fire caused the plane to crash, killing 109 people in the plane and four people on the ground. Beyond the rare tragic incidents, the effects on airline industry are huge.  The FAA requires the absence of FOD within contained spaces in the fuselage.  Inadvertent depositing of materials can cause expensive rework to equipment, slowing down construction and the production lines of manufacturers.  In active duty aircraft FOD causes accidents and damage resulting in significant rework or replacement.  Whether it is items ingested in to engines or broken equipment that damages tires, these pose potential safety issues and are scrupulously monitored by airlines.
foreign object debris - foam earplugs
Disposable foam earplugs are a common form of Foreign Object Debris

Costs of FOD

The replacement cost of a single 737 engine is in the $6-7 million range. Most of the damage occurs on runways, taxiways and aprons.  Lighter damage can lead to flight delays.  More serious issues will keep planes out of service and in need of more expensive repair and rework.  A plane out of service has large downstream effects including lost productivity from flight delays, missed connections and canceled flights.  The FAA estimates that the total costs of FOD to the airline industry exceed $4 billion annually.


On aircraft carriers, prior to beginning flight operations, crews regularly do a shoulder to shoulder sweep of the flight deck to remove all debris.  With safety and reliability at a premium, they ensure that FOD is eliminated.  Military and civilian ground crews regularly check and remove FOD from runways, taxiways and aprons. There are measures that can be taken to reduce if not eliminate FOD. Training should engrain in workers awareness and attention to FOD.  When working in an area keep track of tools, parts, PPE and waste materials.  Tethering gear and equipment helps to keep it organized and prevent FOD.  Create checklists of items and verify that all items are accounted for.  Signage should be prominently placed in critical areas so that the awareness is reinforced.  See an issue, correct and/or report it.  
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Common Hearing Protection Mistakes

Noise Induced Hearing Loss (NIHL) is a progressive, debilitating and preventable condition.  While every effort to protect yourself can be made, here are some common hearing protection mistakes.

Ignoring the problem

How many times have we seen children covering their ears around loud sounds, while adults blissfully absorb the full impact?  Might that be a clue?  Children’s higher sensitivity (and better hearing) are a clear indication of the short term pain/damage and the long term impact of exposure to loud noises.  And yet, we all ignore the problem.  Whether it is a night out at a loud concert or sporting event, or a half hour mowing the lawn, people ignore the problem.  NIHL damage is cumulative and the short bursts from power saws, pneumatic tools and chain saws over time can lead to hearing problems.  Of all of the possible hearing protection mistakes, ignoring the situation is the worst.


Hand in hand with ignoring the problem is ignorance. One of the biggest problems for individuals and companies is not knowing the level of exposure. Following are some charts that indicate the level of noise for various tools and activities:


Almost all common power tools produce higher than safe noise levels.  A decibel meter will reveal how loud a sound is.  A dosimeter gives a measure of how much exposure an individual is receiving.  There are now free Android and Iphone apps that can be downloaded.  (While these are not calibrated, they do provide a good estimate of the level of noise.)

In an industrial environment, proper calibration and analysis is critical to determining the actual exposure for employees.  That entails both using the correct measuring device and understanding the actual exposure while using equipment.  (As an example, a measurement next to a diesel engine is much different than the sound inside the operator’s cab).

One thing to remember is that according to the National Institute of Occupational Safety and Health (NIOSH) the safe exposure threshold for sound is 85 db for 8 hours.  Each 3 db increase above that, halves the daily exposure limits.  The NIOSH daily limits at various volumes are outlined in the chart below:


As is illustrated at some sound levels, no exposure is safe.

Drowning out loud sounds with louder sounds

Using loud music to cover up loud sounds is not a solution.  It’s an even bigger problem.  Headphones or earbuds have the potential to deliver damaging sounds to your ears.  Limiting the usage and turning down the volume are two ways to address this issue.  If other people can hear your music, you are probably at risk of causing long term damage.  If you are around loud noises, use hearing protection, not noise to protect yourself.

Correct level of protection

Being aware of the noise environment, it is important to use the correct level of protection.  Zero protection should not be your first choice.  Thinking that in the short term when mowing the lawn or using a power tool, protection is not important, ignores the real risks.  Other than a real emergency, this should never be a fallback solution.

Secondly some sounds require dual protection.  If you are in an extremely loud environment, it might be important to use both plugs and earmuffs.  If dual protection is needed to reach the correct level of protection, then use it.

Third don’t overprotect.  If you need to take off your safety equipment to hear other employees, then you are probably using too much protection.   Realize, should you need to take off your equipment to hear, you are also less likely to hear safety warnings, or other dangers in your environment.

Proper us and fit

One of the biggest mistakes is improper use or fit.  The proper use of earplugs requires that they be securely fit in the ear canal.  If the plugs are not properly seated, they may provide almost no protection.  When muffs are used, you need to make sure that there is a tight seal as well around the ear.  Glasses and other equipment can cause leaks in the seal.  Again, without a proper fit the hearing protection is significantly compromised.

Replacing worn out equipment

If the muffler on your mower or chainsaw is broken, the level of noise is significantly higher.  The mufflers are designed for both proper operation and noise control of this equipment.  Replace them when they no longer function properly.  Similarly, when your hearing protection is worn out, it is time to replace it with new equipment.  Worn out plugs or muffs no longer provide the level or protection you need to safely operate in a loud environment.

Not realizing it is cumulative

When thinking about hearing protection it is important to remember that the damage is cumulative.  Each damaging exposure slowly reduces the quality of hearing.  While hearing aids allow for communication, they do not the entire range of sounds you once heard.  It is important to protect your hearing and avoid these common hearing protection mistakes.  Start today.

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PE Foam Earplugs: An Environmental Disaster

Millions of American workers use and discard polyurethane foam earplugs every day believing that they are doing what is in the best interest of their health. While the use of this product is highly beneficial for a person’s hearing health, the discarded PU foam plugs ultimately become a serious health hazard for future generations of people who have no direct connection to these workers. In this article we will discuss the ongoing environmental challenges created by polyurethane as well as how eco friendly earplugs are starting to make a difference.

Everyone agrees that PU earplugs protect from the noise exposure risks of construction, industrial manufacturing, shooting, and motorsport. The PU single-use disposable ear plug remains the most common type of hearing protection in use today. Regrettably, hundreds of billions of these earplugs have ended up in public landfills and waterways since they were first introduced to consumers and industrial workplaces more than 40 years ago. As a point of perspective, a single company with 200 employees wearing single use earplugs will dispose of more than half a million single earplugs in landfill within a three year period. PU earplugs never biodegrade, and once buried in landfills the polyurethane ultimately leaches into the ground water tables.


Polyurethane is a synthetic polymer developed in the 1940s, that is often used to replaces rubber, paint, wood, or metals. Polyurethane is found in a wide variety of modern appliances, furnishings, paints, vehicle parts, foam insulation materials, glues, and shoes, among many other applications, and has the advantages of strength, durability and elasticity. Some of the polyurethane used can be recycled into other products, but it all ends as waste eventually. The environmental problem is that once it enters the landfill it could remain there almost indefinitely because nothing we know is able to metabolize and digest it (in other words, it is not biodegradable), and the chemical bonds within it are so strong they do not degrade readily. Polyurethane can be burnt, but this releases harmful carbon monoxide into the atmosphere, along with other toxic chemicals.

There are four categories of earplugs: single use, which are worn once and then replaced when workers reenter a noise area; multiple use, which can be used repeatedly and cleaned with soap and water; banded earplugs, which essentially are two foam earplugs held together by a plastic or metal band; and detectable earplugs, which can be used in environments where you need to be able to screen for foreign substances in the finished product. These are particularly useful in the food processing, tobacco, and paper industries.

Single-Use Earplugs 
Single-use, or disposable, earplugs are the most common type used today. They are popular because of their low cost, ease of use, and high level of comfort. There are different styles, ranging from the 35-year-old yellow PVC barrel earplugs to the latest contoured polyurethane (PU) foam earplugs.

PU earplugs were introduced in the 1980s and have taken over a significant share of the world ear plug market. PU plugs are soft, comfortable, easy to roll down for insertion, and available in a variety of different shapes, sizes, and colors. PU foam is also made in different densities, which means you can get a heavier ear plug that blocks out the maximum amount of noise (NRR 33 is the current max) or a lower density in a smaller shape that exerts less pressure on the ear canal. These are particularly useful for people who wear earplugs for extended periods of time or have smaller ear canals.

Multiple-Use Earplugs 
Reusable earplugs appeal to different types of users and companies. While they are significantly more expensive than disposable foam earplugs, over time they can actually be more economical. If wearers take proper care and maintain their multiple-use earplugs, the dollar spent on a pair can go a lot further than the pennies spent on each pair of single-use earplugs.

Multiple-use earplugs are typically molded with a semi-rigid stem and pliable flanges, so they don’t require rolling prior to insertion. They insert easily and can be quite comfortable for extended periods. Like disposables, most reusable earplugs used to be made of PVC, which has gotten bad press. It’s not a particularly environmentally friendly product, and many of these HPDs end up in a landfill.

Polyurethanes were first produced and investigated by Dr. Otto Bayer in 1937. Polyurethane is a polymer in which the repeating unit contains a urethane moiety. Urethanes are derivatives of carbamic acids which exist only in the form of their esters (Dombrow 1957). This structure can be represented by the following, generalized amide-ester of carbonic acid:


Polyurethane foam is a subset of synthetic plastics.  The main properties of polyurethane foam include the ability to be easily molded into various shapes and the capacity to return to its original shape.  Polyurethane foam comes in three types:  flexible, rigid and viscoelastic (i.e. memory) foam.  These foams are typically either polyether or polyester based polyols, that are not considered to be biodegradable compounds and are obtained from petroleum based resources.


Considering the versatility of polyurethane foam, it is understandable that demand is going to continue to increase with increased usage and application.  At the global level, polyurethane foam utilization reached 8 million tons and was expected to reach 9.6 million tons by 2016.  In 2010, the top consumers included North America, Asia-Pacific and Europe, with 95% of the global demand.


The next question to consider is where all of this polyurethane foam ultimately ends up after it has served its purpose and is no longer of use to the consumer. The answer, in general, is either a landfill or the ocean.  An analysis conducted by Marcus Erikson and colleagues to estimate the amount of plastic pollution currently residing in the world’s oceans found that 92.3% of all samples collected contained plastic materials and of the visual surveys conducted, they identified that the most frequently observed larger plastics were synthetic polymer foams.

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Warning Signs of a Noisy Work Environment

When thinking about noisy work environments, it is common to automatically think of occupations like road work, construction sites, or factories. Although, in reality these noisy work environments can be anywhere. According to Occupational Safety and Health Administration (OSHA), in the matter of just one year, 22 million employees have been exposed to high and dangerous volumes of noise. After this statistic became clear, it was obvious something needed to be done about it. They have since been penalizing companies where hearing safety was not being considered and about $1.5 million in fines overall have been issued.

Signs That the Noise May be at Dangerous Levels

Warnings of high noise volumes may not be noticeable until after you exit the area and usually the signs of the area being too loud will show up later on in the day. Some signs may include ringing, humming, or pain in the ears which is one of the most common signs that you are in an area where ear protection is most definitely needed.

Sometimes even temporary hearing loss, where everything goes completely silent for a short amount of time can happen. Another sign could include having to speak at high volumes just so the person next to you can hear what is trying to be said, when they might only be a few feet away from you. If you have to speak loudly in order for someone to hear you when there is barely any distance in between, that is a clear sign that something is not right with the noise levels in the area.

Can this be Reversed After the Damage is Done?

NIHL, which stands for (noise induced hearing loss) can happen at any age from children to the elderly. The average spent on hearing loss disabilities yearly is estimated to be $242 million, which is an astronomical number when it could have been resolved with protection for the ears. Unfortunately, these signs can either take place immediately or in the future. Sometimes even surgery and/or hearing aids can’t fix or improve this type of hearing loss so it is extremely important to stay on top of the game and fix the issue before it’s too late.

Effects on a Person’s Mental and Physical Health

Can exposure to high level noise environments affect someone’s mental health? The answer to this is yes. Noise can cause numerous problems for your mental health. Some illnesses from high volumes of sound would include Hypersensitivity, insomnia, and even Coronary Artery Disease (CAD) which occurs in the major blood vessels of the heart and is not curable. A past study had actually shown that people who live or work in noisy environments are more likely to be admitted to a hospital for things like a stroke, cardiovascular disorders, and more because of the high noise volumes and the stress it causes on the body.



Husten, Larry. “People Who Live Near Airports at Increased Risk for Cardiovascular Disease.” Forbes, Forbes Magazine, 8 Oct. 2013,

Lisa, Packer. “Advocating for Hearing Health in a Noisy Work Environment.” Healthy Hearing, Advocating for Hearing Health in a Noisy Work Environment, 23 June 2016,

 “UNITED STATES DEPARTMENT OF LABOR.” Occupational Safety and Health Administration, United States Department of Labor,

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Popular Mechanics Names SoundShield® “Innovation of the Month”

We’re pretty excited about this!! Popular Mechanics selected our SoundShield® glasses as “Innovation of the Month” in their September 2016 edition. Popular Mechanics Magazine, which is considered by many to be the “Go To” source for innovative tools and new product reviews, recently named the ReadyMax® SoundShield® safety glasses with retractable hearing protection as the Innovation of the Month. Popular Mechanics is read by an estimated nine million readers each month and they chose the SoundShield® product as part of a review of various hearing protection products from a variety of manufacturers. The popular new product line, which includes numerous styles and lens colors, is gaining widespread usage for many commercial, industrial and DIY applications. The convenient pull-out and easily retractable ear plugs provide the convenience of always having your hearing protection with you when needed. We’re proud to receive such great recognition from this 100+ year-old industry stalwart. LINK:
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DIY and Hobbyist Safety Tips

Accidents caused by DIY or hobbyist work lead to thousands of people ending up in the ER every single year. With the sharp increase in DIYers and hobbyists out there, it is very important to keep safety at the top of your priority list. So, before you power up the table saw or scurry up your aluminum ladder to fix the gutters, here are some DIY and Hobbyist safety tips that could help you prevent a serious accident or injury.

Have a Clean Work Area For Improved Safety

This one is simple and should be the easiest thing in the world for any DIYer to implement. If you keep your work area clean and clear of clutter, you will be less likely to have an accident. Whether you are working in the shop or doing yard work, clean up the area before you start working. Besides the safety benefit, it is also much more enjoyable to work in a clean space!

The 4 to 1 Rule For Safe Ladder Placement


It’s simple. For every 4 feet of ladder height, move the base of the ladder an additional 1 foot from the wall it is resting on. Never use a ladder without reading all warnings and instructions that it came with. Also, make sure that the ladder you are using is the best ladder for the job. The last thing you want to do is put yourself high above the ground only to have to stretch even higher to reach the work area. If the ladder isn’t tall enough, skip the project until you have the proper equipment!

Avoid Unnecessary Fashion Accessories

Things like watches, rings, bracelets, necklaces, etc can be a real hazard when operating machinery or power tools. We hear a lot of talk about wearing baggy or loose clothes when operating power tools, but we rarely hear about accessories. If it dangles away from your body, take it off before working.

Include a First Aid Kit in Your Inventory of Tools


No workshop should ever be without a proper first aid kit. Make sure it is stocked with bandages, anti-bacterial ointment, gauze, and other important items. Keep it easy to access as well. Wouldn’t be much good buried beneath a mountain of other stuff, would it?

For Style AND Safety, Incorporate Better Looking Safety Gear

I know this one seems silly, but there are some very fashionable Safety Glasses out there that you will be more likely to actually use because you don’t feel like a doofus wearing them. The worst safety accessory you could possibly have is the one you won’t use.

DIY and hobbyist safety precautions shouldn’t be any different from general safety precautions. Common sense goes a long way. A great rule to follow is that if something feels in any way unsafe with something you’re working on, stop and reassess the situation. Figure out a safer way of doing the job. With proper safety precautions, we urge everyone to continue tackling jobs around the house and yard!


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OSHA Rules for Eye and Face Protection Have Been Updated

New OSHA rules for eye and face protection were published in the US Federal Register on March 25, 2016. Affected companies–which include all employers operating in general industry, shipyards, longshoring, marine terminals, and construction–should reference the full text of the Federal Register as well as the updated consensus standard which has been incorporated by reference, ANSI/ISEA Z87.1-2010 – Occupational and Educational Personal Eye and Face Protection Devices.

Changes are summarized in a media release from MSA Safety (Doc. ID: 0300-05-MC, April 2010). Noteworthy excerpts with underlined formatting for emphasis:

  • Users will need to be educated on matching the hazard from which they need protection with the marking on the product.The Z87 ASC also made efforts to harmonize with other eye and face protection standards used around the world. Many of the tables in this standard reflect this effort to harmonize with global standards.
  • Extended side protection. Spectacles with thin temples (metal frame or thin plastic) will require side shields if they do not pass the extended side coverage requirements.
  • In Z87.1-2003 protective products are marked as providing “Basic” or “High Impact” protection. In the Z87.1-2010 standard, the products are either non-impact or impact protectors. Products marked as impact protectors must pass all high-impact testing requirements and will be marked as Z87+. Non-impact protectors are those which do not pass all high-impact testing requirements and are therefore marked only with “Z87” (no “+” sign).
  • In the Z87.1-2003 standard, protective products are defined as primary and secondary protectors; primary eye protection should be used under secondary protection (i.e., safety glasses must be worn under visors). This is changing in the Z87.1-2010 standard.

Manufacturers adhering to ANSI/ISEA Z87.1 will be keeping pace with new testing and marking specifications. That said, it takes time to deplete existing inventory, test, adapt, manufacture and distribute new models. Changes are gradual and that is precisely why OSHA is adopting the 2010 standard now, in 2016.

Companies can continue to distribute and use PPE determined by hazard assessment to adequately protect against site and task-specific hazards – even if it is marked according to the specifications of previous 1989 and 2003 versions of the ANSI standard.

As the useful service life of existing PPE requires replacement, companies should ask distributors to provide eye and face protection that bears the newly required markings. But first companies need to reassess and revise eye and face PPE recommendations with increased type, use, shade and filter specificity in mind.

OSHA “direct final rule” cadence incorporating industry requirements from prior years suggests future changes as the consensus evolves. Companies would do well now to consider the newer 2015 version of ANSI/ISEA Z87.1 while referencing the recently incorporated 2010 version.

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