Your Guide to Good PPE
Don't Settle for Sub-Standard PPE - Know The Standards you should be looking for
This guide is not exhaustive but outlines the basic requirements for PPE you should be looking for when buying PPE for your workplace, or for yourself. We will cover nitrile gloves and face masks as the two most used categories of PPE currently, but if you want any further information or guidelines just get in touch and we'd be happy to help.
There is currently a global shortage in the supply of PPE - this is especially the case with Nitrile gloves. Subsequently, numerous companies are manufacturing and supplying nitrile gloves and other products to a sub-par standard or are not providing the correct certifications for these products. Below is our guide to what you need from your supplier to ensure the PPE you are receiving is good quality, and a suitable product for yourself or your workplace
Types of Face Mask and What You Need to Know About Them:
Cotton Masks and Face Coverings - can be made by anyone, with no guidelines, and are broadly ineffectual in terms of COVID - prevention. No particle filtration protection and no certification needed
Non-Graded Disposable Masks - What you see in most retail shops - these have no classification and will generally actually state on the packaging "not for medical use or as PPE" - these have been made following no guidelines and the efficacy of these cannot be gauged at all!
Type I Masks - Type I, and Type I R face masks have a BFE (bacterial filtration efficiency) of 95%, whereas Type II and Type II R face masks have a BFE of 98%. The breathing resistance, and splash resistance for Type I R and Type II R masks, are exactly the same. Type I, I R, II and II R face masks are medical masks tested in the direction of exhalation (inside to outside) and take into account the efficiency of bacterial filtration. Surgical masks of this type stop the wearer from infecting the surrounding environment. They are not effective at protecting the wearer from airbourne diseases such as coronavirus. Remember bacteria are literally thousands of times bigger than viruses…bacterial filtration levels will not do much for virus filtration at all.
Type II Masks - Type II face masks (EN14683) are medical face masks made up of a protective 3 ply construction that prevents large particles from reaching the patient or working surfaces, however they are not effective when blood or bodily fluids are present.
Type IIR Masks - Type IIR face masks are EN14683 certified and are medical face masks made up of a 4 ply construction that prevents large particles from reaching the patient or working surfaces. Type IIR Face masks include a splash resistant layer to protect against blood and other bodily fluids. Type IIR face masks are tested in the direction of exhalation (inside to outside) and take into account the efficiency of bacterial filtration (again not viruses).#
FFP2 Masks - FFP2 face masks are the equivalent of N95 face masks, which meet the guidelines from The World Health Organisation for protection against Covid-19. FFP2 masks have a minimum of 94% filtration percentage and a maximum of 8% leakage to the inside. These masks are not shaped to your face but are simply held in place by the elastic earloop and have a typical lifespan of 3-8 hours depending on environmental factors. These are the first level of filtration that stops viruses.
FFP3 Masks - FFP3 face masks are the most effective at filtration, with a minimum filtration of 99% and a maximum leakage of 2% to the inside. These masks are better shaped to your face for a more snug fit and typically have a valve to help breathe as the filtration material is much thicker. The valve also reduces the build up of moisture, lengthening the lifespan of the mask. FFP3 masks are typically used for handling asbestos.
What are the Standards for Face Masks?
Medical masks and respirators have different standards and regulations, dependent on the geographical area to which they are manufactured.
Medical masks in Europe must comply with the European standard EN 14683, which have 3 levels of bacterial filtration efficiency (BFE1, BFE2, Type R). In the US medical masks must comply with ASTM standards, which have three levels of protection (from low risk of exposure to fluids to high risk of exposure to fluids).
Respirators in Europe must meet European standard EN 149: 2001, which includes three classes of disposable particulate respirators (FFP1, FFP2 and FFP3). In the US respirators must comply with NIOSH (National Institute for Occupational Safety and Health) standards.
Within this standard, there are several classes of respirators depending on the degree of oil resistance:
- Class N: no oil resistance. A distinction is made between N95, N99 and N100. The number after the letter indicates the percentage of filtration of suspended particles.
- Class R: mask resistant to oil for up to eight hours. Here again, a distinction is made between R95, R99 and R100.
- Class P: a completely oil-resistant mask. There are also P95, P99 and P100.
What You Should Be Looking For With Your Nitrile Gloves:
- What Brand are The Nitrile Gloves? - This is the first indicator of the quality of the gloves you will receive. A number of suppliers are currently stating the brand of nitrile gloves you receive when you order will vary dependent on their supply. This should not be the case! Nitrile glove brands vary enormously in quality, thickness and intended use. There is also absolutely no way they can provide you with the correct certification if they do not know the brand they are providing. Do not purchase nitrile gloves if you do not know what brand they are. There are a number of well-known brands of gloves where quality can be assured, and the supplier should be able to confirm this with you on request.
- Are the Gloves actually Nitrile? - Very simply, Nitrile means non-latex, synthesised rubber. Vinyl gloves and Latex gloves are cheaper products and are not made of nitrile rubber. Vinyl gloves and Latex gloves can be perfectly suitable, but Nitrile gloves should be specifically non-latex, as they are more hypo-allergenic and of a higher thickness. A supplier should not be suggesting you compromise when you are specifically looking for Nitrile gloves by suggesting latex or vinyl gloves.
- Are the gloves Powdered or Powder-Free? - Most workplaces and medical care centres require their nitrile gloves to be powder-free, as the powder is a potential allergen. This may not be a requirement for you, but a mark of the quality of the nitrile gloves you are ordering should always be whether this is even specified or not.
- What Certifications Should be Available? - Broadly, there is a minimum set of certifications you should be looking for when purchasing nitrile gloves. For most - EN455 and CE Marking are the two essential requirements, but here is a list of further certifications you may need:
- CE Marked and EN455 - A notified body gives CE certification by providing an EC certificated to PPE Cat III Gloves - This will be reflected in the gloves being CE marked and certified with the EN455 Medical Device Directive.
- EN420:2003 - describes only general standards for
protective gloves such as size, dexterity, package marking and instructions
- EN374-1:2003 - Low chemical protection - Gloves offering Low Chemical Protection are suitable for applications where chemical splash hazards are present.
- EN374-2:2003 - Micro-organism protection - Standard EN374-2 requires glove manufacturers to select and monitor against an Acceptable Quality Level (AQL) for pinhole defects
Lower AQL = lower probability of pinhole defects
A pinhole carries the risk for a micro-organism to pass through
• Assess micro organism risk
• Define hazard classification of the biological agent
• Define size of micro-organism
• Select glove with appropriate Acceptable Quality Level (AQL)
- the lower the AQL, the higher the level of protection
o AQL 1.5 = Level 2
o AQL 0.65 = Level 3
- EN1149-5 - anti-static properties
- EN 388:20030 - mechanical hazards - No thin glove will pass these tests
- EN 407:2004- Thermal hazards - ranked in an ascending number system of 1-4 against 6 categories: Resistance to flammability, Contact heat resistance, Convective heat resistance, Radiant heat resistance, Resistance to small splashes of molten metal, Resistance to large quantities of molten metal.
- EN 511: 2006 - Protection against the cold - assessed against 3 performance levels.
Invisio strives to meet the necessary certifications and requirements with all our products, and we will not sell sub-par products. We believe that during this PPE supply crisis is vitally important that both the retail customers and the medical professionals we supply continue to receive goods of a sufficient standard. There has been evidence of nitrile gloves in particular being sold with no branding or certification to retail customers in the UK.
Please take a look through our catalogue for premium, fully certified PPE and Nitrile gloves.
Also please get in contact with any questions you have about purchasing PPE from us or other suppliers – we are happy to help with what certifications you might need or anything else.
If you require a more specialist PPE product which is not listed in our catalogue, please let us know and we can almost certainly source good quality products for you.