non sterile vinyl gloves - thermofina · powder-free powder-free powder-free ... dotp (dioctyl...
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![Page 1: NON STERILE VINYL GLOVES - Thermofina · powder-free powder-free powder-free ... DOTP (Dioctyl terephthalate), ... (Titanium dioxide, Diisononyl phthalate) N.B. - Do not contain Di-(2-ethylhexyl)](https://reader036.vdocument.in/reader036/viewer/2022062909/5b7a7a197f8b9aad4c8c2a4c/html5/thumbnails/1.jpg)
Hygiene and ease-of-use
NON STERILEVINYL GLOVES
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= Extra-LargeXL9 / 1 0
= LargeL8 / 9
= MediumM7 / 8
= SmallS6 / 7
= Extra-SmallXS5 / 6
Colour codesfor the differentglove sizes
General presentation
Exasyntil®Exanyl®
powder-free powder-free powder-freeExanyl Long®
Product codesXS: 447103XPS: 447103M: 447104L: 447105XL: 447105XG
PackagingBox of 100 glovesCarton of 10 boxes
PackagingBox of 50 glovesCarton of 20 boxes
PackagingBox of 100 glovesCarton of 10 boxes
Product codesXS: 447003XPS: 447003M: 447004L: 447005XL: 447005XG
Classifi cationNon-sterile vinyl examination gloves are non-reusable and are intended for medical use for cross-contamination protectionof the patient and user. They are to be considered "non-invasiveor invasive medical devices for temporary or short-term use"within the meaning of the European directive concerned, and as such are Class I.
Vinyl examination glove, non-sterile, powder-free, ambidextrous, standard cuff minimum 240 mm
Vinyl examination glove, non-sterile, powder-free, ambidextrous, extra-long cuff minimum 290 mm
Stretch vinyl examination glove,non-sterile, powder-free, ambidextrous, standard cuff minimum 240 mm
Product codesS: 447009M: 447010L: 447011(XS and XL on request)
DescriptionThis examination glove is ambidextrous, non-sterile,powder-free, and is made of polyvinyl chloride. Its surface is smooth, the standard vinyl glove is transparent and the stretch vinyl glove is white, and its beaded cuffcomes in a standard length of minimum 240 mm orextra-long length of minimum 290 mm.
DraculaWall mountUniversal box holder(wall mount with screws ordouble-sided adhesive)> Carton of 50 units> Product code: 090002
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Composition (PVC and chemical agents)
Technical specifi cations
Manufacturing process (summary)
Formulation of Exanyl® gloves Formulation of Exasyntil® glovesPVC (Polyvinyl Chloride Resin), DOTP (Dioctyl terephthalate),TXIB (2,2,4-trimethyl-1,3-pentanediol diisobutyrate),Polyurethane Emulsion (Component a: Polyurethane,Component b: Polysiloxane, Component c: Silica), AliphaticHydrocarbon, Organic Hydrocarbon, Ca-Zn stabilizer (Calciumstearate, Zinc stearate)
PVC (Polyvinyl Chloride Resin), DOTP (Dioctyl terephthalate), TXIB(2,2,4-trimethyl-1,3-pentanediol disobutyrate), Polyurethane Emulsion (Component a: Polyurethane, Component b: Polysiloxane, Component c: Silica), Aliphatic Hydrocarbon, Organic Hydrocarbon, Ca-Zn stabilizer (Calcium stearate, Zinc stearate), Elastomer (Adipic Acid Ester) Pigment White (Titanium dioxide, Diisononyl phthalate)
N.B. - Do not contain Di-(2-ethylhexyl) Phthalate (DEHP) and Dibutyl Phthalate (DBP). Do not contain latex, and no animal derivatives.
N.B. - Testing reports and quality certifi cates on request.
N.B. - Inspections and sampling plans all alongthese steps according to Quality System process.
Raw materials reception and inspection
Final shipping
Composition of the mixture
Plastic coatingVinyl dipping
GloveextractionBeading
Pre-shipmentinspection
Filtration
Soaking polyurethane
Visual inspection and selection
Deaeration
Oven drying ofthe polyurethane coating
Packing
Cleaningof forms
Storage
Criteria Standards Results Exanyl®, Exanyl Long®, Exasyntil®
DETECTION OF PINHOLES (tests and level control) EN 455-1 AQL 1.5 (Acceptance Quality Limit)
DIMENSIONS EN 455-2 length 240 mm minimum (and 290 mm min. for long)width Extra-Small: 75 5 mm - Small: 85 5 mm - Medium: 95 5 mm Large: 105 5 mm - Extra-Large: 110 5mm
FORCE AT BREAK EN 455-2before aging 3,6 N at minimumafter aging 70 2°C during 7 days 3,6 N at minimum
SHELF LIFE EN 455-4After storage of 7 days at 70° C°, and 90 days at 50°C° 3 years (recommended)
THICKNESS (SIMPLE) ASTM D5250cuff 0,08 + 0,03 mm (0,09 + 0,03 mm for long)palm 0,11 0,03 mmfi nger 0,09 0,03 mm
ULTIMATE ELONGATION ASTM D5250Before and after aging (70 2°C during 72 h + 2h) 350% minimum for vinyl & 400% minimum for stretch
GLOVES AVERAGE WEIGTH NO 4,5g 0,3 for vinyl and 5,3g 0,3 for stretch normal cuff (M) STANDARD 7g 0,3 for vinyl long cuff (M)
MANUFACTURING PLACE China
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Regulatory symbolaccording to ISO 15223-1
Instructions for use and storage
V09
.17
Double certifi cation M.D./P.P.E.
Quantity, size and CE mark
Recyclablepackaging
Do not reuse single usage
Certifi edfood contact
Slight chemical resistance
Store awayfrom moisture
Store away fromsun and U.V
Resistance to micro-organisms
Readinformation
Batch number (day, month, year
of production)
Expiry date (maximum recommended date)
AcceptanceQuality Limit
Slight chemical
Store away from
micro-organisms
PACKAGINGAND MARKING
THERMOFINAZ.A.C. CHAMLYS - B.P. 13077194 DAMMARIE-LES-LYS FRANCET : 33 (0) 1 64 37 81 96 F : 33 (0) 1 64 37 08 77www.thermofi na.fr
Pallet
Carton
Box
• Complete Europe Pallet of 60 cartons or 600 boxes or 60 000 gloves (30 cartons or 30 000 gloves for LONG)• Possible mix size and/or material by multiple of 10 cartons per layer (6 cartons per layer for LONG)• Dimensions ground 0,80 x 1,20 m
• Average weight 390 kg (290 kg for LONG)• Neat loading, fi lmed labelled and circled with guarantee strip
• Returnable Europe Pallet
• Carton of 10 boxes or 1000 gloves 33 L x 24 H x 24 l approximately (20 boxes of 50 gloves for LONG 45 L x 32 H x 28 l approximately)• Identifi cation of sizes and materials by colour codes, letters and numbers
• Traceability by batch number and expiry date
• Average weight 6,3 kg (9 kg for LONG)• Recyclable material
• Possible customization on request
• Box of 100 gloves (50 gloves for LONG)• Identifi cation of sizes and materials by colour codes, letters and numbers
• Traceability by batch number and expiry date
• Average weight 630 g (450 g for LONG)• Regulatory symbols according to standards in force
• Provision of suitable box holders on request
• Possible customization on request