PRODUCT USER MANUAL
Contents
1. PRODUCT USER MANUAL Nitrile glove PPE Category III complex design GN99 Powder free nitrile blue colour Author Signature Kk funieg r Position QA and Regulatory Affairs Manager Name Karen Gunning Date 23 August 2013 User Manual Ref GN99 Revision Date of Issue 23 August 2013 GN99 Product User Manual 1 Contents Contents page Amendment record sheet Product description and certification e Product compliance performance level attained performance level narrative User information 2 Revision Record Revision Document Number Detail of change Date of Issue Change Note Number oo oe User Manual Ref GN99 Revision Date of Issue 23 August 2013 Product Description and Certification Product Type Disposable examination nitrile gloves Product Classification PPE Category III complex design Generic Suitable for general purpose use medical use and food contact Description and Purpose Waterproof glove with low chemical protection as defined in EN374 1 protective gloves against chemicals and micro organisms Hand Safe nitrile examination gloves GN99 HPC Healthline UK Ltd declares that the PPE described hereafter is in conformity with the provisions of Council Directive 89 686 EEC and where such is the case with the national standard transposing harmonized standard BS EN 420 2003 A1 2009 Protective gloves general requirements and test met2. the gloves shall not leak when tested with air and water For type testing one glove of each size shall be tested with an overall minimum of 4 gloves For production control gloves from a single lot or batch shall be sampled and inspected in accordance with ISO 2859 The inspection levels and acceptable quality levels AQL shall comply with those given in the table below or as agreed between the purchaser and seller if the latter is more stringent Acceptable quality level unit Performance level Inspection levels User Manual Ref GN99 Revision Date of Issue 23 August 2013 4 User and Storage Information User information is displayed on the inner dispenser and outer case The information appears as both written instruction and pictograms The user information and relevant pictograms are detailed in the table below e Product brand name e Description of product e Product code e Product size e Quantity in the dispenser and case e CE mark and reference of directive notified body number e Lot number e Name and address of the manufacturer e Expiry date e Country of origin e Bar code for both inner and outer case e The gloves are powdered or powder free e The gloves contain accelerators ZDEC and ZDBC e The packaging is recyclable e Usage instructions Do not re use single use only see section 9 for the pictogram Safe for food use Waterproof and low chemical protection Micro organism r
3. Transport The GN99 nitrile gloves do not require transport warning as the gloves are not classified as hazardous Further safety information can be obtained from the material safety data sheet available on request
4. esistant e Storage instructions Store in a cool dry place see section 9 for the pictograms Away from direct sunlight or fluorescent light see section 9 for the pictograms User Manual Ref GN99 Revision Date of Issue 23 August 2013 Pictograms Symbol Description Symbol Description CE Mark confirming that products follow requirements of EU Directive Manufacturer 89 686 EEC Personal Protective Equipment Single use only Date of manufacture Keep away from direct sunlight or Lot number fluorescent light Product can be used with the Some elements of the product food industry according to and or packaging are recyclable Pl LI the European Regulation 1935 2004 EN374 waterproof gloves and i EN374 protection against low chemical protection Wair biological hazards Store at temperatures no less an than 5 C and no more than Latex free 25 C i Additional Symbols used by HPC Healthline Acceptable Quality Level of 1 5 EN420 EN374 PPE classification and standards Class Medical Device User Manual Ref GN99 Revision Date of Issue 23 August 2013 Product Efficacy and Usage e The physical properties of the nitrile glove can be altered through the effects of storage temperature light and ozone exposure and were tested under laboratory ambient conditions e The gloves met the requirements of waterproof and low chemical resistance gloves e The gloves do not provide protection aga
5. hods BS EN 347 1 2003 Protective gloves against chemicals and micro organisms Terminology and performance requirements BS EN 347 2 2003 Protective gloves against chemicals and micro organisms Determination of resistance to penetration BS EN 347 3 2003 Protective gloves against chemicals and micro organisms Determination of resistance to permeation Is identical to the PPE which is the subject of EC certificate of conformity no CE 585141 issued by British Standards Institute Group BSi Group Kitemark Court Davy Avenue Knowhill Milton Keynes MK5 8PP United Kingdom Is subject to the procedure set out in Article 11 point A of Directive 89 686 EEC under the supervision of the approved body British Standards Institute Group BSi Group Kitemark Court Davy Avenue Knowhill Milton Keynes MK5 8PP United Kingdom under CE 585148 article 11A User Manual Ref GN99 Revision Date of Issue 23 August 2013 3 Performance Levels Article 10 Certificate CE 585141 BSI Group EC Type Examination Test Data EN420 2003 A1 2009 Dexterity level 5 EN374 2 2003 Resistance to penetration level 2 AQL 1 5 EN347 3 2003 Resistance to permeation 40 Sodium hydroxide K level 6 n Heptane J level 1 EN388 2003 Abrasion resistance level 0 Blade cut resistance level O Tear resistance level 0 Puncture resistance level 0 The GN99 Hand Safe Nitrile Gloves satisfy the requirements e For waterproof and low chemical protecti
6. inst mechanical risk abrasion blade cut tear and puncture e The gloves do not provide protection against cold e The gloves do not provide protection against heat e The gloves do not provide protection against electricity e The gloves are disposable and must be discarded following use They cannot be cleaned and used a second time as this will affect the protective properties of the glove e The gloves should not be used after the expiry date printed on the box three years following date of manufacture e The gloves must not be used should the nitrile film be cracked hardened or display pin holes tears Allergy statement The GN99 nitrile disposable examination gloves contain carbamate accelerators ZDBC and ZDEC which can cause type IV skin irritation and contact dermatitis Storage The GN99 nitrile disposable examination glove properties can be affected by extremes of temperature light and ozone exposure Therefore it is recommended that the gloves are stored in a dry atmosphere between the temperatures of 5 C and 25 C away from direct sunlight fluorescent light or sources of ozone Disposal The GN99 nitrile gloves can be disposed of through normal household waste at approved landfill sites or by high temperature incineration using licensed contractors Disposal must be in accordance with local authority and national regulations Ecological information The GN99 nitrile gloves are not readily biodegradable
7. on gloves EN374 3 2003 e For micro organism resistant gloves EN374 2 2003 level 2 Performance Level and Pictogram Narrative Permeation requirements for BS EN 374 3 2003 necessitate a level 2 performance for three chemicals tested from the list detailed in BS EN 374 1 2008 ADF The fuming flask pictogram would be accompanied by the letter code of each chemical to which the product gained a level 2 performance and be labelled with the beaker pictogram for waterproof and low chemical risk but it must Should a glove not meet the requirements of permeation it can be considered waterproof meet the requirements of BS EN 374 2 2003 and BS EN 420 2003 A glove shall be considered to form an effective barrier to micro biological hazards when it amp conforms to at least level 2 of the penetration test of annex A of EN374 2 2003 User Manual Ref GN99 Revision Date of Issue 23 August 2013 EN374 3 2003 Breakthrough times and list of test chemicals Breakthrough penmeanon Code CAS i performance Chemical Class time min Letter Number Methanol 67 56 1 Primary alcohol B aceone o Acetonitrile 75 05 8 Nitrile compound D Dichloromethane 75 09 2 Chlorinated paraffin Carbon Disulphide 7515 0 Sulphur containing organic compound 108 88 3 Aromatic hydrocarbon Tetrahydrofurane 109 99 9 D E compound 142 85 5 Saturated hydrocarbon Se ace 7664 93 9 Inorganic mineral acid BS EN 374 2 2003 for penetration necessitates that
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