PURPLE NITRILE* Sterile Pairs are excellent for sterile, non-surgical procedures in OB/GYN, ER/Trauma, ICU/CCU, wound care and burn centres. As well as in the handling of biological samples, or in other situations requiring rigourous anti-contamination procedures.
• Meets or exceeds AQL 1,0 in accordance with European Norm 455-1 and 455-2
• CE-marked as Medical Device Class I (93/42/EEC)
• Biocompatible as tested according to ISO 10993 (1-2-5-10-12) which includes primary skin irritation, repeat challenge sensitisation and 200 person modified draize test
• Sterilized in accordance with EN ISO 11137 Sterility Assurance Level (SAL) of 10-6 (Sterile gloves)
• Manufactured in accordance with Quality System EN ISO 13485 and ISO 9001.
Update November 2020
The UK Government offered a temporary VAT holiday on PPE products from May 1st to October 31st 2020. Although this has now come to an end and VAT is once again chargeable on PPE products, a group of expert GAMBICA members including Camlab have come together to recommend to HMRC that all PPE used in charitably funded medical and veterinary research be eligible for zero rate VAT. You can learn more about this effort here.
In these continuing unprecedented times we have had to deal with product supply restrictions, monthly price increases and surcharges being placed on our purchase orders for goods, particularly for critical Personal Protective Equipment (PPE).
Throughout the ongoing global pandemic we have strived to limit any increases to the selling price of all our main PPE brands. However, due to continued shortages and unprecedented high demand globally, we are seeing monthly cost price increases imposed by many of our PPE suppliers for items such as gloves and respirators . Some national governments have also restricted access to PPE products, and in some cases are applying additional export surcharges. Main manufacturers are also being asked to prioritise front line care workers.
Unfortunately from this point on we will have to include any additional government or increased freight surcharges applied to these products. To help mitigate such increases, we set up a PPE sourcing team in Q2 2020 tasked to source reliable alternative global manufacturers of these types of products in short supply to be able to offer our customers alternative similar products. Through this effort we continue to find cost effective alternatives and we are happy to work with our customers purchasing departments to try and negotiate bulk discount prices.
As products become available we will list them here.
Although we now have to pass on increases and surcharges please be assured that we are not inflating our profits. We are doing our best to overcome shortages by sourcing products from alternative suppliers of PPE, but in some cases the prices of these products are significantly above normal due to demand and in other cases they do not meet the correct PPE regulations that could put the public or medical professionals at risk if sold improperly. We are working with Trading Standards Institute (TSI) and the British Safety Industry federation (BSIF) by reporting these suppliers/providers who we believe are wrongly exploiting the current situation.
Unfortunately we are also finding that unscrupulous suppliers are offering us counterfeit products. Camlab is a member of the BSIF and we are working closely with them to ensure the items we source and sell are properly CE EN/149 rated and tested accordingly. Please note that category III products require much stricter requirements including ongoing market surveillance. Reporting and documentation retention is considerably more onerous on manufactures, suppliers and customers for Health and Safety records, recall, notification and withdrawal purposes.
We wish all our customers well in these trying times and hope we can all return to business as normal as soon as possible
To help our Scientific and Industrial customers find and choose the best products to achieve the right results.
Our Core values
Choice • Service • Trust
Useful Information – Things to Check
Is your supplier a member of the BSIF – https://www.bsif.co.uk/
Has your supplier verified this product and has documentation available?
Medical devices EU regulations
The European Union Medical Device Regulation repeals the existing directives on medical devices: Medical Devices Directive [93/42/EEC] and Active Implantable Medical Device Directive [90/385/EEC]. The regulation was published on 5 May 2017 and came into force on 25 May 2017
European Union (EU) Medical Device Regulation (MDR) 2017/745
The standards, which cover face masks, medical gloves and protective clothing are listed below: