KN95 Protective Face Mask Announcement

KN95 Protective Face Mask

Can a KN95 mask be used in dental practices in the UK and what specification must they meet to be safe and compliant for UK Dental Practices?

With the global outbreak of COVID-19; surgical masks, respirators and other personal protective equipment are in short supply, therefore interim guidance has now endorsed the use of FFP2 or equivalent masks for dental procedures in the UK. KN95 masks are a Chinese standard PPE respiratory face mask which, under normal circumstances have a different intended use than a surgical mask. There has been concern regarding both the quality of the mask and lack of compliance with European standards of some supplies of KN95 face masks. Please see below FAQs for KN95 masks:

Frequently Asked Questions

HSE have issued a statement that KN95 must not be used as their effectiveness cannot be assured. There has been concern regarding the both the quality of some KN95 face masks in the marketplace and the lack of compliance with European standards.

If the required specifications are NOT met the masks should not be used. However KN95 masks ARE safe, compliant and approved for use in UK dental practices IF they meet the below requirements: 1) Masks must be CE marked.

2) Suppliers must be able to demonstrate how they know the documentation and CE marking is genuine, supported by Notified Body documentation showing compliance with the essential health and safety requirements as required by the Personal Protective Equipment Regulations (EU) 2016/425.

Are KN95 the same as FFP2 Masks?

KN95 is a performance rating under the Chinese standard GB2626:2006, the requirements of which are broadly the same as the European standard BSEN149:2001+A1:2009 for FFP2 facemasks. The technical specifications for N95 (USA), KN95 (China) and FFP2 are similar and are recognised as being equivalent in terms of performance and functionality. Most FFP2s offer at least 94% filtration of particles. HSE and PHE have concluded that they provide comparable protection if the wearer has passed a face fit test. WHO guidelines state : “Personnel should wear a particulate respirator at least as protective as a NIOSH-certified N95, an EU standard FFP2, or the equivalent�. The technical specifications for N95, KN95 and FFP2 are similar (with the exception of the paraffin oil test) and are recognised as being equivalent in terms of performance and functionality

Do a I need a fit test, what does it involve, does every different type of mask need a test?

A face-fit test is required to be carried out by a competent person (https://www.hse.gov.uk/news/face-mask-ppe-rpecoronavirus.htm). Fit-testing typically takes 30 minutes and comprises of qualitative fit-testing, testing whether the wearer can taste an intensely bitter or sweet substance sprayed into the ambient air, or quantitative fit testing which measures the ratio of particles in the air inside and outside the breathing zone when wearing the respirator. Formal Fit testing must be performed by an accredited person prior to the first wear of a respirator. If the wearer changes a brand of mask a new fit test must be carried out.

It is always recommended the fit test is not booked until the masks are received.

sales@henryschein.co.uk

0800 023 2558

henryschein.co.uk

Please visit http://www.henryschein.co.uk/gb-en/Dental-GB/LegalTerms.aspx for full terms and conditions. E & OE.

I have put on my mask and still have gaps. Can I get a refund if it doesn’t pass the fit test?

Everyone’s face shape is different and there is no “one size fits all” for any type of respirator. It’s possible that a number of different brands of masks may be required for the whole team. Adjustments can be made to respirators which may allow for a suitable fit. Face mask strap fasteners can be used to address issues with loose masks which don’t fit tightly enough, but also to eliminate any uncomfortable tightness around the wearer’s ears. If using a face mask which has elastic loops, this simple strap fastener will allow you to secure them behind your head by simply wrapping the mask’s elastic straps around the clip, rather than your ears, this will immediately relieve pressure, or tighten the fit. This should be discussed with the fit tester. PPE is non- returnable unless faulty. However for KN95 masks we will offer a refund for any unopened boxes if they do not pass a fit test. To qualify for a KN95 refund we must be notified of the intention to return the goods within 30 days of receipt. This is in addition to the standard terms & conditions which can be found on our website.

The packaging says “Not for Medical”

Due to current Chinese export rules, PPE from China may have packaging marked “Non-Medical” or “Not for Medical”. This does not impact the European certification or the efficacy of the KN95 Mask.

What is the difference between valved and non-valved?

The valve is a comfort device for the wearer - a small plastic section that is fitted to the front of the mask. It allows air to escape as you breathe out, meaning temperatures are better regulated and the mask can be worn more comfortably for a longer period of time. However it only filters air breathed in, but not air breathed out. The valve opens when exhaling which may let out unfiltered particles. Non-valved masks provide two-way filtering protection for the wearer but also better protection for the patient.

Risk Assessments

In light of the recent changes to PPE requirements and the changes surrounding aerosol-generating procedures within dental practices, a risk assessment should be carried out. This should include assessment of the fundamental change in infection control policy as well as consideration of the use of masks conforming to equivalent standards to FFP2. This risk assessment allows the clinician to rationalise the purchase of an N95 or KN95 mask in light of the current lack of available options due to limited supplies of respirators in the market. For maximum protection during aerosol-generating procedures, current UK guidelines recommend that a full-face visor should also be worn.

Further Information

https://multimedia.3m.com/mws/media/1791500O/comparison-ffp2-kn95-n95-filtering-facepiece-respirator-classes-tb.pdf https://www.hse.gov.uk/coronavirus/ppe-face-masks/index.htm https://www.hse.gov.uk/pubns/disposable-respirator.pdf

https://www.gov.uk/government/publications/wuhan-novel-coronavirus-infection-prevention-and-control/managing-shortagesin-personal-protective-equipment-ppe https://www.gov.uk/government/publications/wuhan-novel-coronavirus-infection-prevention-and-control/covid-19-personalprotective-equipment-ppe#section-10 https://www.hse.gov.uk/safetybulletins/use-of-face-masks-designated-kn95.htm https://www.hse.gov.uk/coronavirus/ppe-face-masks/index.htm

sales@henryschein.co.uk

0800 023 2558

henryschein.co.uk

Please visit http://www.henryschein.co.uk/gb-en/Dental-GB/LegalTerms.aspx for full terms and conditions. E & OE.

Now in Stock

KN95 Earloop Respirator Mask [CE Certified PPE Product] Item Code: 1198802 Pack Size: 20 masks per pack 1 - 9 packs: £58.99 each Cost per mask: £2.95 10 - 29 packs: £45.00 each Cost per mask: £2.25 30+ packs: £20.00 each Cost per mask: £1.00

High quality professional KN95 face mask, with soft and highly elastic ear bands for maximum comfort. Ergonomic 3D fold-flat design provides a comfortable fit, wide field of view and good adherence to the face, while being easy to store. Three-layer construction with a blown melt non-woven filtration layer providing >=95% filter performance. Non-valved design provides two-way filtering, helping to protect both the wearer and patient. Our Regulatory department has obtained and validated the product documentation to confirm that these masks meet European FFP2 specifications and conform with the CE mark specifications in compliance with EU PPE Regulations 2016/425, allowing you to shop with confidence.

This certified protective mask conforms to both EN 149:2001+A1:2009 (FFP2) and GB2626-2006 (KN95) standards, and is CE marked under PPE Regulation (EU) 2016/425. Please note this mask may be marked with the KN95 standard only.

The packaging is also be marked “Non-Medical”. This is due to current Chinese export rules and does not impact the efficacy or European certification of the product.

• • • • • • • • • • • •

Non-valved K95 earloop respirator mask High density filter material with filtration efficiency ≥95% Three-layer construction with blown melt non-woven filtration layer Ergonomic 3D fold-flat design provides a comfortable fit, wide field of view and good adherence to the face, while being easy to store Waterproof non-woven fabric Aluminium nose piece fits exactly to the bridge of the nose Soft and highly elastic ear bands to help provide a tight fitting Can be worn for extended periods without pain to the ears CE certified to PPE EU 2016/425 Meets both EN 149:2001+A1:2009 (FFP2) and GB2626-2006 (KN95) standards Colour : White Approximate size 105x160mm

Please be advised that the G950 KN95/FFP2 face mask is a PPE respiratory mask which, under normal circumstances, has different intended use than a surgical mask which is a medical product. Interim guidance raised during the COVID-19 outbreak recommends FFP2 masks to be used also for dental procedures according to local dental association guidelines. Henry Schein Regulatory has obtained and validated the product documentation to confirm that these masks meet all EU FFP2 specifications and as such are fully tested and CE certified under the EU PPE Regulation.

sales@henryschein.co.uk

0800 023 2558

henryschein.co.uk

Please visit http://www.henryschein.co.uk/gb-en/Dental-GB/LegalTerms.aspx for full terms and conditions. E & OE.