every thing you touch we touch - iranpharmis.org

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Page 1: Every thing you touch We touch - iranpharmis.org

Every thing you touch...We touch

Page 2: Every thing you touch We touch - iranpharmis.org
Page 3: Every thing you touch We touch - iranpharmis.org

ERGONOMIC SURGICAL GLOVES

Ref-11976-20151205

ENCORE® MICROPTIC®ENHANCED DEXTERITY WITH AN ANTI-SLIPFINISH FOR PROCEDURES REQUIRING ADELICATE TOUCH

ENCORE® MicrOptic® gloves have been designed to meet the increasingdemand for the best possible tactile attributes. Thanks to their high level oftactile sensitivity (20% thinner than the standard surgical glove*, thesegloves are ideal for delicate surgical procedures.

The ENCORE® MicrOptic® is ideal for delicate procedures in ophthalmic,micro, and cardiothoracic surgery. Its micro-thickness allows forcomfortable double-gloving, and its brown colour reduces glare fromsurgical lights.

Offering Ansell’s SureFit™ technology to prevent cuff roll-down, and anextraordinary strength-to-thickness ratio, this glove provides healthcareprofessionals with superior barrier protection.

This securing glove that offers the perfect level of sensitivity features apolyurethane inner coating which is resistant to alcohol-based handdisinfectants, adding another layer of safety between the skin and thelatex.

Moreover, ENCORE® MicrOptic® has a very low protein content (30 μg/gor less of water/extractable protein per gram), and its specific latexformulation with reduced use of chemical accelerators minimises the riskof skin irritation.

*ENCORE® Style 85

PRODUCT DESCRIPTION

Material Natural Rubber LatexColour BrownShape AnatomicCuff SureFit™ technology: Beaded

cuff with adhesive bandExternal Surface Micro-textured, chlorinated &

siliconizedInternal Surface Polyurethane coated &

siliconized

SIZE / PRODUCT CODE

5.5 5787100EU 6 5787101EU6.5 5787102EU 7 5787103EU7.5 5787104EU 8 5787105EU8.5 5787106EU 9 5787107EU

ENCORE® gloves are designed and engineered for surgeons, ORnurses and surgical technicians seeking protection and safety withadvanced levels of ergonomics, dexterity and comfort duringsurgery. ENCORE® gloves afford the kind of hand protection thatelevates users’ confidence and provide optimum comfort duringsurgery.

Natural Latex Powder-Free Sterile Surgical Glove

MD Class IIaRegistering Authority: British Standards Institution (0086): MD, British StandardsInstitution (0086): PPEIf relevant, read carefully the instructions for use flyer accompanying theproduct. Single use only. Sterile unless this package is opened or damaged.This product contains natural rubber latex which may cause allergic reactions,including anaphylactic responses.

Ansell is a world leader in providing superior health and safety protection solutions that enhance human well being. With operations in North America, Latin America, EMEA and Asia, Ansellemploys more than 13,000 people worldwide and holds leading positions in the industrial and medical gloves market, as well as in the sexual health and wellbeing category worldwide. Anselloperates in four main business segments: Medical Solutions, Industrial Solutions, Specialty Markets and Sexual Wellness. Information on Ansell and its products can be found atwww.ansell.eu.

Page 4: Every thing you touch We touch - iranpharmis.org

TECHNICALDATASHEET

ENCORE®Ergonomic Surgical Gloves

ENCORE® MicrOptic®Natural Latex Powder-Free Sterile Surgical Glove Issue date 05-12-2015

PRODUCT DESCRIPTION

Material Natural Rubber LatexColour BrownShape AnatomicCuff SureFit™ technology: Beaded cuff with

adhesive bandExternal Surface Micro-textured, chlorinated & siliconizedInternal Surface Polyurethane coated & siliconized

PHYSICAL PROPRETIES

Thickness (single)Typical average values(mm)

Finger 0,180Palm 0,150Cuff 0,120

Minimum length (mm) 295

Strength (averagevalues)

before ageing after ageing

Elongation at Break(%)

816 899

Force at break (N) 13 13

PACKAGING AND STORAGE

Packaging 4 x 50 pairs / 200 pairs per caseShelf Life 3 yearsStorage Instructions Keep out of direct sunlight. Store in a cool and

dry place. Keep away from sources of ozone orignition.

PRODUCT REFERENCES

Size / product code 5.5 5787100EU 6 5787101EU6.5 5787102EU 7 5787103EU7.5 5787104EU 8 5787105EU8.5 5787106EU 9 5787107EU

KEY FEATURES AND ADVANTAGES

Brown to reduce effective glare•Dexterity•Secure grip•Tactile sensitivity•

MANUFACTURING AND SAFETY STANDARDS

AQL (pinholes) Waterleak tested•Conform European Norm EN 455-1:Inspection Level I AQL 1.5

•Manufacturing Final Release:Inspection Level I AQL 1.0

•In process control before packaging:Inspection Level I AQL 0.65

Protein content Very low level: Typical results < 30 µg/g forModified Lowry & HLPC (EN 455-3)

Pyrogenicity Absent of pyrogens as per ISO 10993-11

Primary skin irritation Not considered a primary irritant as per FHSARegulation guidelines 16 CFR 1500

Skin Sensitization No evidence of delayed dermal contactsensitization as per ISO 10993-10

Viral Penetration Passes Ansell's AVPP dynamic testing•Passes ASTM F 1671 using Phi X 174•Passes LGM/CDRH (FDA) using Phi X174

Cytostatic Permeation ACPP tested under dynamic conditions

Sterilization 25 kGγ Gamma irradiation

CE Mark Medical Device: Class IIaPersonal Protective Equipment: Category III

Product StandardsConformance

EN 455 parts 1, 2, 3, 4EN 374 parts 1, 2, 3EN 420

ManufacturingStandards

EN 556ISO 11137-1ISO 13485ISO 14001ISO 9001

Registering Authority British Standards Institution (0086): MDBritish Standards Institution (0086): PPE

PICTOGRAMS

EN374 EN374

Please consult the Instruction for Use.

Page 5: Every thing you touch We touch - iranpharmis.org

ERGONOMIC SURGICAL GLOVES

Ref-11801-20151205

ENCORE® ORTHOPAEDIC30% THICKER THAN OTHER ENCORE®GLOVES* FOR ADDED TEAR AND PUNCTUREPROTECTION

The tear and puncture resistance and tensile strength of ENCORE®Orthopaedic surgical gloves help withstand the rigors of high-risk, traumaand reconstructive procedures.

The extra thickness of the ENCORE® Orthopaedic makes this glove 40%more resistant than standard powder-free surgical gloves. It features atextured finish for superior grip when handling instruments and sutures,with a brown colour to reduce glare from surgical lighting.

Offering Ansell’s SureFit™ technology to prevent cuff roll-down, this gloveprovides healthcare professionals with superior barrier protection.

This securing glove features polyurethane inner coating resistant toalcohol-based hand disinfectants, adding another layer of safety betweenthe skin and the latex.

Moreover, ENCORE® Orthopaedic has a very low protein content (30 μg/gor less of water/extractable protein per gram) and its specific latexformulation with reduced use of chemical accelerators minimises the riskof skin irritation.

*ENCORE® Style 85

PRODUCT DESCRIPTION

Material Natural Rubber LatexColour BrownShape AnatomicCuff SureFit™ technology: Beaded

cuff with adhesive bandExternal Surface Textured, chlorinated &

siliconizedInternal Surface Polyurethane coated &

siliconized

SIZE / PRODUCT CODE

5.5 5788200EU 6 5788201EU6.5 5788202EU 7 5788203EU7.5 5788204EU 8 5788205EU8.5 5788206EU 9 5788207EU

ENCORE® gloves are designed and engineered for surgeons, ORnurses and surgical technicians seeking protection and safety withadvanced levels of ergonomics, dexterity and comfort duringsurgery. ENCORE® gloves afford the kind of hand protection thatelevates users’ confidence and provide optimum comfort duringsurgery.

Natural Latex Powder-Free Sterile Surgical Glove

MD Class IIaRegistering Authority: British Standards Institution (0086): MD, British StandardsInstitution (0086): PPEIf relevant, read carefully the instructions for use flyer accompanying theproduct. Single use only. Sterile unless this package is opened or damaged.This product contains natural rubber latex which may cause allergic reactions,including anaphylactic responses.

Ansell is a world leader in providing superior health and safety protection solutions that enhance human well being. With operations in North America, Latin America, EMEA and Asia, Ansellemploys more than 13,000 people worldwide and holds leading positions in the industrial and medical gloves market, as well as in the sexual health and wellbeing category worldwide. Anselloperates in four main business segments: Medical Solutions, Industrial Solutions, Specialty Markets and Sexual Wellness. Information on Ansell and its products can be found atwww.ansell.eu.

Page 6: Every thing you touch We touch - iranpharmis.org

TECHNICALDATASHEET

ENCORE®Ergonomic Surgical Gloves

ENCORE® OrthopaedicNatural Latex Powder-Free Sterile Surgical Glove Issue date 05-12-2015

PRODUCT DESCRIPTION

Material Natural Rubber LatexColour BrownShape AnatomicCuff SureFit™ technology: Beaded cuff with

adhesive bandExternal Surface Textured, chlorinated & siliconizedInternal Surface Polyurethane coated & siliconized

PHYSICAL PROPRETIES

Thickness (single)Typical average values(mm)

Finger 0,330Palm 0,300Cuff 0,260

Minimum length (mm) 295

Strength (averagevalues)

before ageing after ageing

Elongation at Break(%)

922 901

Force at break (N) 28 27

PACKAGING AND STORAGE

Packaging 4 x 50 pairs / 200 pairs per caseShelf Life 3 yearsStorage Instructions Keep out of direct sunlight. Store in a cool and

dry place. Keep away from sources of ozone orignition.

PRODUCT REFERENCES

Size / product code 5.5 5788200EU 6 5788201EU6.5 5788202EU 7 5788203EU7.5 5788204EU 8 5788205EU8.5 5788206EU 9 5788207EU

KEY FEATURES AND ADVANTAGES

Brown colour reduces light reflection•Extra thick for increased protection•Outstanding physical properties•Textured surface delivers outstanding wetand dry grip

MANUFACTURING AND SAFETY STANDARDS

AQL (pinholes) Waterleak tested•Conform European Norm EN 455-1:Inspection Level I AQL 1.5

•Manufacturing Final Release:Inspection Level I AQL 1.0

•In process control before packaging:Inspection Level I AQL 0.65

Protein content Very low level: Typical results < 30 µg/g forModified Lowry & HLPC (EN 455-3)

Pyrogenicity Absent of pyrogens as per ISO 10993-11

Primary skin irritation Considered a negligible irritant as per ISO10993-10

Skin Sensitization No evidence of delayed dermal contactsensitization as per ISO 10993-10

Viral Penetration Passes Ansell's AVPP dynamic testing•Passes ASTM F 1671 using Phi X 174•Passes LGM/CDRH (FDA) using Phi X174

Cytostatic Permeation ACPP tested under dynamic conditions•ASTM D6978 Breakthrough Timesavailable

Sterilization 25 kGγ Gamma irradiation

CE Mark Medical Device: Class IIaPersonal Protective Equipment: Category III

Product StandardsConformance

EN 455 parts 1, 2, 3, 4EN 374 parts 1, 2, 3EN 420EN 388

ManufacturingStandards

EN 556ISO 11137-1ISO 13485ISO 14001ISO 9001

Registering Authority British Standards Institution (0086): MDBritish Standards Institution (0086): PPE

PICTOGRAMS

EN374 EN374 EN3880 0 1 0

Please consult the Instruction for Use.

Page 7: Every thing you touch We touch - iranpharmis.org

ERGONOMIC SURGICAL GLOVES

Ref-07781-20151205

ENCORE® STYLE 42®SATIN-MICROTEXTURED FINISHPROVIDES MAXIMUM TACTILESENSITIVITY

The ENCORE® Style 42® has been designed to provideuncompromising quality and durability in a standard latex surgicalglove.

Its smooth finish offers maximum tactile sensitivity while theadvanced used technology lowers powder and protein levels.

Offering Ansell’s SureFit™ technology to prevent cuff roll-down, theglove provides healthcare professionals with superior barrierprotection.

Moreover, ENCORE® Style 42® has a very low protein content (50μg/g or less of water/extractable protein per gram), and its specificlatex formulation with reduced use of chemical acceleratorsminimises the risk of skin irritation.

PRODUCT DESCRIPTION

Material Natural Rubber LatexColour WhiteShape AnatomicCuff BeadedExternal Surface Micro-texturedInternal Surface Powdered*

* Donning powder: Modified corn starch (USP)

SIZE / PRODUCT CODE

5.5 303531 6 3035326.5 303533 7 3035347.5 303535 8 3035368.5 303537 9 303538

ENCORE® gloves are designed and engineered for surgeons, ORnurses and surgical technicians seeking protection and safety withadvanced levels of ergonomics, dexterity and comfort duringsurgery. ENCORE® gloves afford the kind of hand protection thatelevates users’ confidence and provide optimum comfort duringsurgery.

Natural Latex Powdered Sterile Surgical Glove

MD Class IIaRegistering Authority: British Standards Institution (0086): MDIf relevant, read carefully the instructions for use flyer accompanying theproduct. Single use only. Sterile unless this package is opened or damaged.This product contains natural rubber latex which may cause allergic reactions,including anaphylactic responses.

Ansell is a world leader in providing superior health and safety protection solutions that enhance human well being. With operations in North America, Latin America, EMEA and Asia, Ansellemploys more than 13,000 people worldwide and holds leading positions in the industrial and medical gloves market, as well as in the sexual health and wellbeing category worldwide. Anselloperates in four main business segments: Medical Solutions, Industrial Solutions, Specialty Markets and Sexual Wellness. Information on Ansell and its products can be found atwww.ansell.eu.

Page 8: Every thing you touch We touch - iranpharmis.org
Page 9: Every thing you touch We touch - iranpharmis.org

ERGONOMIC SURGICAL GLOVES

Ref-07841-20151205

ENCORE® ULTRAOUTSTANDING PROTECTION FOR USERSWITH TYPE I (LATEX) AND TYPE IV(CHEMICAL ACCELERATOR) ALLERGIES

ENCORE® Ultra is a powder-free surgical glove made of Neoprene.

Accelerator-free, the new SENSOPRENE® formulation delivers anexceptional surgical glove offering unprecedented comfort and sensitivitywith advanced allergy protection.

No chemicals (thiurams, MBT, carbamates) known to contribute to Type IVallergies are used, making it safe for latex-sensitive (Type I) and chemical-sensitive (Type IV) healthcare professionals and patients.

New ENCORE® Ultra gloves protect healthcare workers and patientsagainst additional causes of skin reactions with features such as casein-free formulation - to minimise reactions to animal proteins - and CPC-freepolymer coating – thus eliminating irritation caused by cetylpyridiniumchloride (CPC).

With its new creamed colour, it offers enhanced tactile sensitivity in thefingertips and allows for easy and comfortable double gloving.

Offering Ansell’s SureFit™ technology to prevent cuff roll-down,ENCORE® Ultra provides healthcare professionals with superior barrierprotection.

PRODUCT DESCRIPTION

Material NeopreneColour CreamShape AnatomicCuff SureFit™ technology: Beaded

cuff with adhesive bandExternal Surface Micro-textured, chlorinated &

siliconizedInternal Surface Polyurethane coated &

siliconized

SIZE / PRODUCT CODE

5.5 353311 6 3533126.5 353313 7 3533147.5 353315 8 3533168.5 353317 9 353318

ENCORE® gloves are designed and engineered for surgeons, ORnurses and surgical technicians seeking protection and safety withadvanced levels of ergonomics, dexterity and comfort duringsurgery. ENCORE® gloves afford the kind of hand protection thatelevates users’ confidence and provide optimum comfort duringsurgery.

Neoprene Powder-Free Sterile Surgical Glove

MD Class IIaRegistering Authority: British Standards Institution (0086): MDIf relevant, read carefully the instructions for use flyer accompanying theproduct. Single use only. Sterile unless this package is opened or damaged.

Ansell is a world leader in providing superior health and safety protection solutions that enhance human well being. With operations in North America, Latin America, EMEA and Asia, Ansellemploys more than 13,000 people worldwide and holds leading positions in the industrial and medical gloves market, as well as in the sexual health and wellbeing category worldwide. Anselloperates in four main business segments: Medical Solutions, Industrial Solutions, Specialty Markets and Sexual Wellness. Information on Ansell and its products can be found atwww.ansell.eu.

Page 10: Every thing you touch We touch - iranpharmis.org
Page 11: Every thing you touch We touch - iranpharmis.org

ERGONOMIC SURGICAL GLOVES

Ref-25001-20151205

ENCORE® STYLE 85TEXTURED FINISH FOR A MORERELIABLE GRIP

The Encore® Style 85 has been designed to meet the needs ofusers who want a glove with a rough surface for the sure handlingof instruments, with maximum comfort and safety levels.

Offering Ansell’s SureFit™ technology to prevent cuff roll-down, thisglove provides healthcare professionals with superior barrierprotection.

This securing glove features polyurethane inner coating resistant toalcohol-based hand disinfectants, adding another layer of safetybetween the skin and the latex.

Moreover, ENCORE® Style 85 has a very low protein content (30μg/g or less of water/extractable protein per gram) and its specificlatex formulation with reduced use of chemical acceleratorsminimises the risk of skin irritation.

PRODUCT DESCRIPTION

Material Natural Rubber LatexColour WhiteShape AnatomicCuff SureFit™ technology: Beaded

cuff with adhesive bandExternal Surface Textured, chlorinated &

siliconizedInternal Surface Polyurethane coated &

siliconized

SIZE / PRODUCT CODE

5.5 5785200EU 6 5785201EU6.5 5785202EU 7 5785203EU7.5 5785204EU 8 5785205EU8.5 5785206EU 9 5785207EU

ENCORE® gloves are designed and engineered for surgeons, ORnurses and surgical technicians seeking protection and safety withadvanced levels of ergonomics, dexterity and comfort duringsurgery. ENCORE® gloves afford the kind of hand protection thatelevates users’ confidence and provide optimum comfort duringsurgery.

Natural Latex Powder-Free Sterile Surgical Glove

MD Class IIa & PPE Cat. IIIRegistering Authority: British Standards Institution (0086): MD, British StandardsInstitution (0086): PPEIf relevant, read carefully the instructions for use flyer accompanying theproduct. Single use only. Sterile unless this package is opened or damaged.This product contains natural rubber latex which may cause allergic reactions,including anaphylactic responses.

Ansell is a world leader in providing superior health and safety protection solutions that enhance human well being. With operations in North America, Latin America, EMEA and Asia, Ansellemploys more than 13,000 people worldwide and holds leading positions in the industrial and medical gloves market, as well as in the sexual health and wellbeing category worldwide. Anselloperates in four main business segments: Medical Solutions, Industrial Solutions, Specialty Markets and Sexual Wellness. Information on Ansell and its products can be found atwww.ansell.eu.

Page 12: Every thing you touch We touch - iranpharmis.org

TECHNICALDATASHEET

ENCORE®Ergonomic Surgical Gloves

ENCORE® Style 85Natural Latex Powder-Free Sterile Surgical Glove Issue date 05-12-2015

PRODUCT DESCRIPTION

Material Natural Rubber LatexColour WhiteShape AnatomicCuff SureFit™ technology: Beaded cuff with

adhesive bandExternal Surface Textured, chlorinated & siliconizedInternal Surface Polyurethane coated & siliconized

PHYSICAL PROPRETIES

Thickness (single)Typical average values(mm)

Finger 0,230Palm 0,205Cuff 0,170

Minimum length (mm) 295

Strength (averagevalues)

before ageing after ageing

Elongation at Break(%)

889 894

Force at break (N) 19 18

PACKAGING AND STORAGE

Packaging 4 x 50 pairs / 200 pairs per caseShelf Life 3 yearsStorage Instructions Keep out of direct sunlight. Store in a cool and

dry place. Keep away from sources of ozone orignition.

PRODUCT REFERENCES

Size / product code 5.5 5785200EU 6 5785201EU6.5 5785202EU 7 5785203EU7.5 5785204EU 8 5785205EU8.5 5785206EU 9 5785207EU

KEY FEATURES AND ADVANTAGES

Anatomic curved former for less handfatigue

•Better grip due to textured surface•Easy donning•Good comfort•

MANUFACTURING AND SAFETY STANDARDS

AQL (pinholes) Waterleak tested•Conform European Norm EN 455-1:Inspection Level I AQL 1.5

•Manufacturing Final Release: InspectionLevel I AQL 1.0

•In process control before packaging:Inspection Level I AQL 0.65

Protein content Very low level: Typical results < 30 µg/g forModified Lowry & HLPC (EN 455-3)

Pyrogenicity Absent of pyrogens as per ISO 10993-11

Primary skin irritation Not considered a primary irritant as per FHSARegulation guidelines 16 CFR 1500

Skin Sensitization No evidence of delayed dermal contactsensitization as per ISO 10993-10

Viral Penetration Passes Ansell's AVPP dynamic testing•Passes ASTM F 1671 using Phi X 174•Passes LGM/CDRH (FDA) using Phi X174

Cytostatic Permeation ACPP tested under dynamic conditions•ASTM D6978 Breakthrough Timesavailable

Sterilization 25 kGγ Gamma irradiation

CE Mark Medical Device: Class IIaPersonal Protective Equipment: Category III

Product StandardsConformance

EN 455 parts 1, 2, 3, 4EN 374 parts 1, 2, 3EN 420

ManufacturingStandards

EN 556ISO 11137-1ISO 13485ISO 14001ISO 9001

Registering Authority British Standards Institution (0086): MDBritish Standards Institution (0086): PPE

PICTOGRAMS

EN374 EN374

Please consult the Instruction for Use.

TECHNICALDATASHEET

ENCORE®Ergonomic Surgical Gloves

ENCORE® Style 85Natural Latex Powder-Free Sterile Surgical Glove Issue date 05-12-2015

PRODUCT DESCRIPTION

Material Natural Rubber LatexColour WhiteShape AnatomicCuff SureFit™ technology: Beaded cuff with

adhesive bandExternal Surface Textured, chlorinated & siliconizedInternal Surface Polyurethane coated & siliconized

PHYSICAL PROPRETIES

Thickness (single)Typical average values(mm)

Finger 0,230Palm 0,205Cuff 0,170

Minimum length (mm) 295

Strength (averagevalues)

before ageing after ageing

Elongation at Break(%)

889 894

Force at break (N) 19 18

PACKAGING AND STORAGE

Packaging 4 x 50 pairs / 200 pairs per caseShelf Life 3 yearsStorage Instructions Keep out of direct sunlight. Store in a cool and

dry place. Keep away from sources of ozone orignition.

PRODUCT REFERENCES

Size / product code 5.5 5785200EU 6 5785201EU6.5 5785202EU 7 5785203EU7.5 5785204EU 8 5785205EU8.5 5785206EU 9 5785207EU

KEY FEATURES AND ADVANTAGES

Anatomic curved former for less handfatigue

•Better grip due to textured surface•Easy donning•Good comfort•

MANUFACTURING AND SAFETY STANDARDS

AQL (pinholes) Waterleak tested•Conform European Norm EN 455-1:Inspection Level I AQL 1.5

•Manufacturing Final Release: InspectionLevel I AQL 1.0

•In process control before packaging:Inspection Level I AQL 0.65

Protein content Very low level: Typical results < 30 µg/g forModified Lowry & HLPC (EN 455-3)

Pyrogenicity Absent of pyrogens as per ISO 10993-11

Primary skin irritation Not considered a primary irritant as per FHSARegulation guidelines 16 CFR 1500

Skin Sensitization No evidence of delayed dermal contactsensitization as per ISO 10993-10

Viral Penetration Passes Ansell's AVPP dynamic testing•Passes ASTM F 1671 using Phi X 174•Passes LGM/CDRH (FDA) using Phi X174

Cytostatic Permeation ACPP tested under dynamic conditions•ASTM D6978 Breakthrough Timesavailable

Sterilization 25 kGγ Gamma irradiation

CE Mark Medical Device: Class IIaPersonal Protective Equipment: Category III

Product StandardsConformance

EN 455 parts 1, 2, 3, 4EN 374 parts 1, 2, 3EN 420

ManufacturingStandards

EN 556ISO 11137-1ISO 13485ISO 14001ISO 9001

Registering Authority British Standards Institution (0086): MDBritish Standards Institution (0086): PPE

PICTOGRAMS

EN374 EN374

Please consult the Instruction for Use.

Page 13: Every thing you touch We touch - iranpharmis.org
Page 14: Every thing you touch We touch - iranpharmis.org

Every thing you touch...We touch