SUPPORT PACK. Nitra-Touch

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1 SUPPORT PACK Nitra-Touch

3 SUPPORT PACK Nitra-Touch 3 TABLE OF CONTENTS 1. Nitra-Touch Brochure 4 2. General product information 8 3. Technical Datasheet 9 4. CE Certificate Declaration of Conformity Food Declaration of Product Compliance Chemical Permeation Breakthrough Times Cytostatic Permeation Breakthrough Times Ansell Cytostatic Permeation Program EN455-1 Absence of pinholes & EN455-2 Physical properties FitKit Protein Contents Gemelli Rome Hospital chooses Nitra-Touch Visit our Nitra-Touch website 32

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8 GENERAL PRODUCT INFORMATION 8

9 TECHNICAL DATASHEET 9

10 CE CERTIFICATE 10

11 DECLARATION OF CONFORMITY 11

12 FOOD DECLARATION OF PRODUCT COMPLIANCE 12

13 CHEMICAL PERMEATION BREAKTHROUGH TIMES 13 Chemical agent Breakthrough Protection CAS number Test Lab Standard Time (min) Index 1,1,1-trichloro-2-methyl-2-propyl alcohol in Peanut oil > Centexbel 1-Methoxy-2-Propanol Centexbel Acetonitrile 73% + Methyl Alcohol 25% + Ammonia 2% 1 0 Centexbel Acetic acid, glacial Satra Acrylic acid < Centexbel Acrylamide, 40 % > Force Technology Allylchloride < Centexbel Ammonia, 25 % Centexbel Anioxyde TM 1000 > Force Technology Benzyl alcohol Centexbel Bromochloromethane Centexbel Butyl alcohol Centexbel Cacodylic acid, sodium salt hydrat buffer 0.1 M > Centexbel Caffeine 1.6 % > Centexbel Carbon disulfide < Centexbel Chlorobutane < Centexbel Chloroform Centexbel

14 14 Chemical agent Breakthrough Protection CAS number Test Lab Standard Time (min) Index Cidex TM > Force Technology Cidex TM OPA > Force Technology Cyclohexane > Centexbel Cyclohexanone < Centexbel Dibromoethane < 20 sec Centexbel Dibromomethane < Centexbel Dichloroethane < 20 sec. 0 Centexbel Diesel > Centexbel Diethylamine Centexbel Diethyl ether < 40 sec Centexbel Dimethylformamide < Centexbel Dimethyl sulfoxide Centexbel Ditranol 0.7 % in liquid paraffin thin Centexbel Ethidiumbromide, saturated > Centexbel Ethyl acetate Centexbel Ethyl alcohol, 70 % Centexbel Ethyl alcohol, 95 % Centexbel Ethylacetate 86% + Methyl Alcohol 9% + Ammonia 5% Centexbel Formaldehyde 4% in Phosphatebuffer > Centexbel Formaldehyde 24.5 % > Centexbel Formaldehyde, 35 % > Centexbel

15 15 Chemical agent Breakthrough Protection CAS number Test Lab Standard Time (min) Index Gasoline Centexbel Glutaraldehyde, 50 % > Centexbel Glutaric dialdehyde 2.5%, cacodylic acid, sodium salt > Centexbel Heptane > Centexbel Heptane 98% + 1-butyl alcohol 2% Centexbel Heptane 98% + 3-methyl-1-butyl alcohol 2% Centexbel Hexane > Centexbel Hydrochloric acid, 37 % Centexbel Hydrofluoric acid, 48 % < Centexbel Hydrogen Bromide, 49% > Centexbel Hydrogen peroxide, 30 % Centexbel Iso-octane > Centexbel Isopropyl Alcohol Centexbel Isopropanol 70% Centexbel Kerosene > Centexbel Methanol Centexbel Methyl-t-butyl Ether Centexbel Methyl ethyl ketone < Centexbel Methyl Isobutyl ketone Centexbel

16 16 Chemical agent Breakthrough Protection CAS number Test Lab Standard Time (min) Index Methyl mehacrylate Force technology Methyl Sulfoxide 5% in Citratebuffer > Centexbel Methyl sulfoxide 20 % in RMP1640 culture 80 % >480 6 Centexbel Methylviolet 1 % > Centexbel Nicotine Force Technology Nitric acid, 50 % Centexbel Nitric acid, 70 % < Centexbel Peracetic acid, 39 % Force Technology Perchloroethylene Centexbel Potassium Permanganate 5 % Centexbel Salicyclic Acid 2 % in Peanut oil > Centexbel Sodium Hydroxide, 50 % > Centexbel Sulphuric acid, 50 % > Centexbel Sulphuric acid, conc Centexbel Tetrahydrofuran < Centexbel Tetrahydrofuran/n-Heptan, ratio 60%-40% < 5 0 Centexbel Toluene Centexbel Triethylamine Centexbel Undecane > Centexbel White Spirit Centexbel Xylene < Centexbel

17 CYTOSTATIC PERMEATION BREAKTHROUGH TIMES 17 Chemotherapy drug and Breakthrough Protection Test Lab Standard Concentration Time (min) Index Busulfan, 6mg/ml (6,000ppm) Dacarbazine (DTIC), 10.0 mg/ml (10,000 ppm) Docetaxel, 10.0 mg/ml (10,000 ppm) Fludarabine, 25 mg/ml (25,000 ppm) Gemcitabine (Gemzar), 38 mg/ml (38,000 ppm) Idarubicin, 1 mg/ml (1,000 ppm) Ifosfamide, 50.0 mg/ml (50,000 ppm) Irinotecan, 20.0 mg/ml (20,000 ppm) Melphalan, 5 mg/ml (5,000 ppm) Oxaliplatin, 5 mg/ml (5,000 ppm) Vinblastine, 1 mg/ml (1,000 ppm)

18 18 Chemotherapy drug and Breakthrough Protection Test Lab Standard Concentration Time (min) Index Bleomycin Sulfate 15.0 mg/ml ( ppm) Carboplatin 10.0 mg/ml ( ppm) Carmustine 3.3 mg/ml (3 300 ppm) Cisplatin 1.0 mg/ml (1 000 ppm) Cyclophosphamide 20.0 mg/ml ( ppm) Cytarabine Hydrochloride mg/ml (1 000 ppm) Doxorubicin Hydrochloride 2.0 mg/ml (2 000 ppm) Etoposide 20.0 mg/ml ( ppm) Fluorouracil 50.0 mg/ml ( ppm) Ifosfamide 50 mg/ml ( ppm) Mechlorethamine Hydrochloride 1.0 mg/ml (1 000 ppm) Methotrexate 25.0 mg/ml ( ppm) Mitomycin C 0.5 mg/ml (500 ppm) Mitoxantrone mg/ml ( ppm) Paclitaxel (Taxol) 6.0 mg/ml (6 000 ppm) Thio-Tepa 10 mg/ml ( ppm) Vincristine Sulfate 50.0 mg/ml ( ppm) Vinorelbine Tartrate 10 mg/ml ( ppm)

19 ANSELL CYTOTASTIC PERMEATION PROGRAM 19

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24 EN455-1 ABSENCE OF PINHOLES & EN455-2 PHYSICAL PROPERTIES 24

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27 FITKIT PROTEIN CONTENTS 27

28 ISO 9001 CERTIFICATE 28

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GEMELLI ROME HOSPITAL CHOOSES NITRA-TOUCH The facility is one of Italy s major multi-disciplinary oncology centres, with over 3,000 healthcare professionals.

Maddalena Pozzi, Nurse Epidemiologist, Healthcare Management Department at Gemelli Hospital: The hospital was created as a project of Father Agostino Gemelli, founder and first Chancellor of the

It followed on from the Faculty of Medicine and Surgery, with the intention of offering patient compassion, excellence, highly specialised care, continuous medical innovation, and the training of

Stefano Pepe, Nurse, Haematology Day Hospital: The haematology department is essentially subject to two types of risk: firstly biological risk, and secondly chemical risk.

31 GEMELLI ROME HOSPITAL CHOOSES NITRA-TOUCH The facility is one of Italy s major multi-disciplinary oncology centres, with over 3,000 healthcare professionals. On a yearly bases 40,000 people are treated in the Oncology and Haematology Centre, receiving more than 35,000 chemotherapy treatments. Maddalena Pozzi, Nurse Epidemiologist, Healthcare Management Department at Gemelli Hospital: The hospital was created as a project of Father Agostino Gemelli, founder and first Chancellor of the Catholic University of the Sacred Heart. It followed on from the Faculty of Medicine and Surgery, with the intention of offering patient compassion, excellence, highly specialised care, continuous medical innovation, and the training of workers according to the bioethical principles of the magisterium of the Catholic Church. Stefano Pepe, Nurse, Haematology Day Hospital: The haematology department is essentially subject to two types of risk: firstly biological risk, and secondly chemical risk. Regarding biological risk, this involves the part dedicated to, shall we say, patient excreta, while chemical risk relates to the issue of handling antiblastic drugs. The Oncology and Haematology Centre is the biggest multidisciplinary oncology centre in the Lazio region in terms of the number of cases handled, and one of the foremost in the country. Lucia Pavan, Hospital Pharmacist: Concerning cytotoxics, we wanted maximum protection for our staff, by selecting gloves with excellent resistance and impermeability. The healthcare management department has provided staff with all necessary guidance for the correct use of the gloves in the various situations where their use is required. When we chose Nitra-Touch TM gloves, we didn t have any substances that caused us any special concern, however the hospital wanted to provide the maximum protection for its staff by selecting gloves with high resistance and impermeability. In addition, the permeability to different cytostatics was tested under dynamic conditions in the ACPP (Ansell Cytostatic Permeation Program). Because the gloves are tested in dynamic physical conditions it simulates reality and is undoubtedly very reliable. Prior to making their final decision on their choice of gloves, Gemelli Hospital tested various alternatives. Next to the superior protection the high comfort level of Nitra-Touch TM was a decisive factor. For the Gemelli Hospital the safety of its healthcare workers comes first. The hospital adheres to stringent procedures for the selection of its protective equipment. By choosing Nitra- Touch it has opted for the gloves with the highest resistance grades for handling cytotoxic preparations. Patricia Porta, Nursing Coordinator, Medical Oncology Day Hospital: The Ansell Nitra-Touch gloves certainly have a good fit - you only need to pay a little attention when putting them on to warm them for a few seconds in your hands, and then they fit perfectly like a second skin. 31 Watch video on:

VISIT THE NITRA-TOUCH WEBSITE 32 The Ansell Nitra-Touch website brings together all campaign materials. There are 3 dedicated landing pages, each focussing on a different aspect of Nitra-Touch. 1.

On this webpage the visitor can: Download the Nitra-Touch brochure Request the Nitra-Touch Sample Box 2. www.nitratouch.

The focus is on the rigorous chemical testing that the glove has been submitted to by independent labs.

32 VISIT THE NITRA-TOUCH WEBSITE 32 The Ansell Nitra-Touch website brings together all campaign materials. There are 3 dedicated landing pages, each focussing on a different aspect of Nitra-Touch This web page offers the visitor an overview of the Nitra-Touch features, advantages and benefits. On this webpage the visitor can: Download the Nitra-Touch brochure Request the Nitra-Touch Sample Box This web page offer the visitor an insight in the proven superior protection aspects of Nitra-Touch. The focus is on the rigorous chemical testing that the glove has been submitted to by independent labs. A basic result comparison between Nitra- Touch and standard 6N nitrile equivalents is being presented, and the link with the Ansell Cytostatic Permeation Program is made. Furthermore, the visitor is invited to connect with Ansell in case there are hazardous chemicals that he is handling in his workplace, which is currently not on the listed of tested chemicals. On this page the visitor can: Download the Nitra-Touch test results for over 100 chemicals and chemotherapy drugs Request a chemical test Download the ACPP brochure Download the Nitra-Touch brochure Request the Nitra-Touch Sample Box On this page the visitor is presented the Gemelli Rome Hospital testimonial. On this page the visitor can: Watch the Gemelli Hospital video Download the full Gemelli Hospital story (Pdf) Download the Nitra-Touch brochure Request the Nitra-Touch Sample Box

33 NOTES 33

Vasco OP Free Sterile Surgical and Protective Gloves

Vasco OP Free Sterile Surgical and Protective Gloves DATA SheeT EN 374:2003 EN 374:2003 AQl 0.65 B. Braun Melsungen AG confirms that Vasco OP Free gloves comply with the following standards and directives: ec certificates AnD APPlieD STAnDArDS Medical device