SHIELDskin Orange 300 Sterile Individually Wrapped Nitrile Powder Free Gloves - 20 Pairs x 8

IVD - Approved for medical Use

Medical Device Class 1 (MDD) according to the Directive 93/42/EEC.

VAT FREE?

These gloves are classed as medical devices and as such have a VAT free status for research organisations who provide suitable documentation at point of order. If you are ordering online please state your requirement for VAT free in the order comments box or contact our sales office on 01954 233 110.

Dear Customer,

In these unprecedented times we have to deal with more product supply restrictions, price increases and surcharges being placed on our purchase orders for goods, particularly for critical Personal Protective Equipment (PPE).

It is important to note that many of these products are bought in foreign currency (dollars and euros) and due to recent large movements in exchange rate this has also negatively impacted the sterling cost price resulting in selling price increases. We intend to continue to provide all our main brands at normal list prices for as long as we can at this time although it is now clear that due to shortages and high demand national governments are restricting access to PPE products and in some cases 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 are setting up a PPE sourcing team to try and find alternative global manufacturers of these types of products in short supply to be able to offer our customers alternative similar products. We hope to be able to find cost effective alternatives and we are happy to work with our customers purchasing departments to try and negotiate bulk discount prices.

As they become available we will list them here https://www.camlab.co.uk/products/products-in-stock

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

Camlab mission:

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/

 Is the product CE marked correctly?

 Have you a copy of the EU Declaration of Conformity?

 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

PPE Standards

The standards, which cover face masks, medical gloves and protective clothing are listed below:

• BS EN 149:2001+A1:2009 Respiratory protective devices. Filtering half masks to protect against particles. Requirements, testing, marking
• BS EN 166:2002 Personal eye protection. Specifications
• BS EN 14126:2003 Protective clothing. Performance requirements and tests methods for protective clothing against infective agents
• BS EN 14605:2009+A1:2009 Protective clothing against liquid chemicals. Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4])
• BS EN 13795-1:2019 Surgical clothing and drapes. Requirements and test methods. Surgical drapes and gowns
• BS EN 13795-2:2019 Surgical clothing and drapes. Requirements and test methods. Clean air suits
• BS EN 455-1:2000 Medical gloves for single use. Requirements and testing for freedom from holes
• BS EN 455-2:2015 Medical gloves for single use. Requirements and testing for physical properties
• BS EN 455-3:2015 Medical gloves for single use. Requirements and testing for biological evaluation
• BS EN 455-4:2009 Medical gloves for single use. Requirements and testing for shelf life determination
• BS EN 14683:2019 Medical face masks. Requirements and test methods.
• BS EN ISO 10993-1:2009 Biological evaluation of medical devices. Evaluation and testing within a risk management process
• BS EN ISO 374-5:2016 Protective gloves against dangerous chemicals and micro-organisms. Terminology and performance requirements for micro-organisms risks
• BS EN ISO 13688:2013 Protective clothing. General requirements
• BS EN 13795-1:2019 Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
• BS EN 29073-3:1992 Methods of tests for Nonwovens - Part 3: Determination of tensile strength and elongation
• BS EN ISO 139:2005 Textiles - Standard atmospheres for conditioning and testing
• BS EN ISO 811:2018 Textiles - Determination of resistance to water penetration - Hydrostatic pressure test
• BS EN ISO 9073-10:2004 Textiles - Test methods for nonwovens - Part 10:  Lint and other particles generation in the dry state
• BS EN ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
• BS EN ISO 11737-1:2018 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
• BS EN ISO 13938‑1:2019 Textiles - Bursting properties of fabrics - Part 1: Hydraulic method for determination of bursting strength and bursting distension
• BS EN ISO 22612:2005 Clothing for protection against infectious agents — Test method for resistance to dry microbial penetration
• ISO 22610:2018 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Test method to determine the resistance to wet bacterial penetration