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Gs-0127_e.pdf

Engineered for Protection, Designed for Comfort KIMTECH PURE!"G3 Sterile STERLING* Nitrile Gloves
KIMTECH PURE* G3 Sterile STERLING* Improved Performance
Nitrile Gloves offer Improved Performance Our innovative STERLING* manufacturing technology
and Comfort and are Better for the enables us to deliver a comfortable nitrile glove with all the
protection and cleanliness our customers have come to expect. The result is a sterile nitrile glove combining the • Recommended for ISO Class 3 or higher cleanroom sensitivity of latex with the protection of nitrile. • Contain no natural rubber latex reducing the potential When double-donned, the KIMTECH PURE* G3 Sterile for TYPE I glove-associated reactions STERLING* Nitrile Gloves deliver the equivalent thickness • Static dissipative in use of a single latex glove without the risk of Type I latex • Safe handling of objects due to improved and allergic reactions. This improves feel & dexterity without any loss in barrier protection or performance. • Hand specific Better For The Environment
• Walleted & pouched in polyethylene for cleanroom use The KIMTECH PURE* G3 Sterile STERLING* Nitrile Glove is also an environmentally responsible glove that requires • Packaged for aseptic donning fewer raw materials to produce. We have improved • Certificate of Analysis (by Lot) and Certificate of packaging to deliver 50% more gloves per case than Irradiation available online traditional gloves. Average use of 25 cases per month • Trend Data available online to demonstrate product results in reduction of 1,000 kg of waste per year vs. quality over time traditional latex gloves. PACKAGED FOR
EXCELLENT DEXTERITY
& TACTILE SENSITIVITY
KIMTECH PURE! G3 Sterile
* Nitrile Gloves
• Synthetic nitrile polymer (Acrylonitrile Butadiene) • Contains no natural rubber latex. BEADED CUFF
30cm LENGTH
TEXTURED
• This is a PPE Category III product classified by EC Council Directive 89/686/EEC. It is tested in accordance with the EN Norms EN420:2003 • Cleanroom packaged to meet the standard of ISO Class 3 Cleanroom • Meets or exceeds AQL level of 1.5 for pinholes • Manufactured in accordance with Quality System ISO 9001 • Dexterity Classification (EN 420:2003) = 5 PHYSICAL PROPERTIES (Target values)
Test Method
Freedom from holes EN374-1 and ASTM D 5151 1 AQL as defined per ISO 2859-1 for sampling by attributes
Tensile Properties
Tensile Strength
ASTM D 412 and ASTM D 573 - After Accelerated Aging Dimensional
Measured Point
- Nominal Thickness ASTM D 3767 and D 6319 Palm Widths
- Nominal Width (mm)
ASTM D 3767 / D 6319 and EN420 Particles (maximum)
- Per cm2 > 0.5 micron
Endotoxin (maximum)
- Endotoxin Units/pair
LAL Kinetic Turbidimetric Method KIMTECH PURE!"G3 Sterile STERLING! Nitrile Gloves
Reduce Today, Respect Tomorrow is the KIMBERLY-CLARK PROFESSIONAL*approach to sustainability. It begins with the understanding that the way we use resources today shapes the world of tomorrow. And it has led us to focus on reducing consumption at every stage of the product lifecycle – from design and manufacture to distribution and disposal. Reduction is the key to lowering the environmental impact of our activities as well as those of customers. It has also been crucial in achieving our number one position five years in a row on the Dow Jones Sustainability Index. To learn more about Reduce Today, Respect Tomorrow and how we can reduce consumption in your business, visit www.kcpreducetoday.com
INFORMATION SERVICE For technical enquiries please email [email protected] sales enquiries please email [email protected] * Trademark of Kimberly-Clark Worldwide, Inc., or its affiliates. 2009 KCWW. Publication code: 4535.01 GB 08.09 Email: [email protected]
06 April 2010
SUBJECT: Cytotoxic Drug Permeation testing of KIMTECH PURE* G3 Sterile STERLING* Nitrile
gloves

Dear Valued Customer
Thanks for your enquiry about our KIMTECH PURE* G3 Sterile STERLING* Nitrile gloves and
their use with cytotoxic substances.
First we must caution that the selection of the most appropriate product for a specific task should
be carried out by a trained safety professional following a full risk assessment. It is Kimberly-
Clark's intent to provide data which can enable trained professionals to make an informed choice.
The aforementioned gloves have been tested for permeation with the range of cytotoxic substances
below. Testing was performed according to ASTM D 6978-05 Standard Practice for Assessment of
Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Three replicate specimens
were tested per substance on the cuff area of the glove, corresponding to the location where
minimum glove thickness is observed.
AVERAGE BREAKTHROUGH TIME TESTED CYTOTOXIC DRUG Cyclophosphamide No breakthrough up to 240 min. Paclitaxel (Taxol) No breakthrough up to 240 min. No breakthrough up to 240 min. No breakthrough up to 240 min. No breakthrough up to 240 min. Vincristine sulfate No breakthrough up to 240 min. No breakthrough up to 240 min. No breakthrough up to 240 min. No breakthrough up to 240 min. No breakthrough up to 240 min. No breakthrough up to 240 min. No breakthrough up to 240 min. No breakthrough up to 240 min. No breakthrough up to 240 min. No breakthrough up to 240 min. No breakthrough up to 240 min. Analysis has been carried out under laboratory conditions and should be only considered as a guide for use. Breakthrough times quoted may not be representative of workplace durations of protection due to other factors that may affect performance (abrasion, temperature, degradation etc.). Selection and risk analysis associated with this personal protective equipment is the responsibility of the user. We hope this information has been helpful. If we can assist further please let us know at [email protected] Regards INFOFAX Service Kimberly-Clark Professional* Europe INFOFAX REFERENCE IB13249 SUBJECT: Cytotoxic Drug Permeation testing of KIMTECH* gloves
Dear Valued Customer,
Thank you for your enquiry about our gloves and their use for protection against chemical splash hazards by
cytotoxic drugs.
We must caution that the selection of the most appropriate glove for a specific task should be carried out by a
trained safety professional following a full risk assessment. It is Kimberly- Clark's intent to provide data which can enable trained professionals to make an informed choice. This letter contains the results of chemical permeation testing of cytotoxic drugs, performed on the following KIMTECH PURE* G3 Sterile White Nitrile gloves KIMTECH PURE* G3 Sterile STERLING* NITRILE gloves KIMTECH PURE* G3 STERLING* NITRILE gloves KIMTECH PURE* G5 STERLING* NITRILE gloves KIMTECH SCIENCE* STERLING* NITRILE gloves and STERLING* NITRILE-XTRA gloves KIMTECH SCIENCE* PURPLE NITRILE* gloves and PURPLE NITRILE-XTRA* gloves. The following test standards are referenced in this letter: EN374-3:2003 (Protective gloves against chemicals and micro-organisms; Part 3: Test for determination of resistance to permeation by chemicals) ASTM D 6978-05 (Standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs) KIMTECH PURE* G3 Sterile White Nitrile gloves were tested according to EN374-3:2003, adapted with a reduction in swatch area chamber size, making it possible to use much smaller amounts of the toxic donor solution compared to the standard method. Results: Drug and Concentration
Carmustine (3.3 mg/ml) No breakthrough up to 180 minutes Cisplatin (0.5 mg/ml) No breakthrough up to 180 minutes Doxorubicin (2.0 mg/ml) No breakthrough up to 180 minutes Etoposide (20.0 mg/ml) No breakthrough up to 180 minutes Fluorouracil (20.0 mg/ml) No breakthrough up to 180 minutes Ironotecan (20.0 mg/ml) No breakthrough up to 180 minutes Methotrexate (100.0 mg/ml) No breakthrough up to 180 minutes ThioTEPA (10.0 mg/ml) No breakthrough up to 180 minutes Vinorelbine (10.0 mg/ml) No breakthrough up to 180 minutes Tests were carried out by an independent laboratory, under laboratory test conditions. These tests may not adequately replicate any specific condition of use, and because KIMBERLY-CLARK has no detailed knowledge or control over the conditions of end use, any of these data must be advisory only, and KIMBERLY-CLARK must decline any liability. KIMTECH PURE* G3 Sterile STERLING* NITRILE gloves were tested according to ASTM D 6978-05 Standard Test Method for Resistance of Protective Clothing materials to Permeation by Liquids or Gases under Conditions of Continuous Contact. Results: Drug and Concentration
Breakthrough time
Cyclophosphamide (20.0 mg/ml) No breakthrough up to 240 minutes Paclitaxel (Taxol) (6.0 mg/ml) No breakthrough up to 240 minutes Doxorubicin (2.0 mg/ml) No breakthrough up to 240 minutes Carmustine (3.3 mg/ml) Dacarbazine (10.0 mg/ml) No breakthrough up to 240 minutes Toposar (Etoposide) (20.0 mg/ml) No breakthrough up to 240 minutes Thiotepa (10.0 mg/ml) Vincristine sulfate (1.0 mg/ml) No breakthrough up to 240 minutes Cisplatin (0.5 mg/ml) No breakthrough up to 240 minutes Mitoxantrone (2.0 mg/ml) No breakthrough up to 240 minutes Ifosfamide (50.0 mg/ml) No breakthrough up to 240 minutes Docetaxel (10.0 mg/ml) No breakthrough up to 240 minutes Gemcitabine (38.0 mg/ml) No breakthrough up to 240 minutes Cytarabine (100.0 mg/ml) No breakthrough up to 240 minutes Irinotecan (20.0 mg/ml) No breakthrough up to 240 minutes Fluorouracil (50.0 mg/ml) No breakthrough up to 240 minutes Oxaliplatin (50.0 mg/ml) No breakthrough up to 240 minutes Carboplatin (10.0 mg/ml) No breakthrough up to 240 minutes Tests were carried out by an independent laboratory, under laboratory test conditions. These tests may not adequately replicate any specific condition of use, and because KIMBERLY-CLARK has no detailed knowledge or control over the conditions of end use, any of these data must be advisory only, and KIMBERLY-CLARK must decline any liability. Warning: Do not use this glove when there is a risk of exposure to splash hazards by Carmustine and Thiotepa. KIMTECH PURE* G3 STERLING* NITRILE gloves, KIMTECH PURE* G5 STERLING* NITRILE gloves, KIMTECH SCIENCE* STERLING* NITRILE gloves and KIMTECH SCIENCE* STERLING* NITRILE-XTRA gloves, are made from the same formulation, processing techniques as KIMBERLY-CLARK* STERLING* Nitrile gloves, were tested according to ASTM D 6978-05. Results: Drug and Concentration
Breakthrough time
Carmustine (3.3mg/ml) Cyclophosphamide (20.0 mg/ml) No breakthrough up to 240 minutes Doxorubicin HCl (2.0mg/ml) No breakthrough up to 240 minutes Etoposide (20.0 mg/ml) No breakthrough up to 240 minutes 5-Fluorouracil (50.0mg/ml) No breakthrough up to 240 minutes Paclitaxel (Taxol) (6.0mg/ml) No breakthrough up to 240 minutes ThioTEPA (10.0mg/ml) Cisplatin (1.0mg.ml) No breakthrough up to 240 minutes Dacarbazine (10.0 mg/ml) No breakthrough up to 240 minutes Ifosfamide (50.0mg/ml) No breakthrough up to 240 minutes Mitoxantrone (2.0mg/ml) No breakthrough up to 240 minutes Vincristine sulphate (1.0mg/ml) No breakthrough up to 240 minutes Tests were carried out by an independent laboratory, under laboratory test conditions. These tests may not adequately replicate any specific condition of use, and because KIMBERLY-CLARK has no detailed knowledge or control over the conditions of end use, any of these data must be advisory only, and KIMBERLY-CLARK must decline any liability. Warning: Do not use this glove when there is a risk of exposure to splash hazards by Carmustine and Thiotepa. KIMTECH SCIENCE* PURPLE NITRILE* gloves and KIMTECH SCIENCE* PURPLE NITRILE-XTRA* gloves, are made from the same formulation, processing techniques as KIMBERLY-CLARK* PURPLE NITRILE* gloves, were tested according to ASTM D 6978-05. Results: Drug and Concentration
Breakthrough time
Bleomycin sulfate (15.0 mg/ml) No breakthrough up to 240 minutes Busulfan (6.0mg/ml) No breakthrough up to 240 minutes Carboplatin (10.0mg/ml) No breakthrough up to 240 minutes Cisplatin (1.0 mg/ml) No breakthrough up to 240 minutes Cyclophosphamide (20.0 mg/ml) No breakthrough up to 240 minutes Cytarabine HCL (100.0 mg/ml) No breakthrough up to 240 minutes Dacarbazine (10.0 mg/ml) No breakthrough up to 240 minutes Daunombicin HCL (5.0 mg/ml) No breakthrough up to 240 minutes Docetaxel (10.0 mg/ml) No breakthrough up to 240 minutes Doxorubicin HDC (2.0 mg/ml) No breakthrough up to 240 minutes Ellence (Epirubicin) (2.0 mg/ml) No breakthrough up to 240 minutes Etoposide (20.0 mg/ml) No breakthrough up to 240 minutes Fludarabine (25.0 mg/ml) No breakthrough up to 240 minutes Fluorouracil (50.0 mg/ml) No breakthrough up to 240 minutes Gemcitabine (38.0 mg/ml) No breakthrough up to 240 minutes Idarubicin (1.0 mg/ml) No breakthrough up to 240 minutes Ifosfamide (50.0 mg/ml) No breakthrough up to 240 minutes Irinotecan (20.0 mg/ml) No breakthrough up to 240 minutes Mechlorethamine (1.0 mg/ml) No breakthrough up to 240 minutes Melphalan (5.0 mg/ml) No breakthrough up to 240 minutes Methotrexate (25.0 mg/ml) No breakthrough up to 240 minutes Mitomycin (0.5 mg/ml) No breakthrough up to 240 minutes Mitoxantrone (2.0 mg/ml) No breakthrough up to 240 minutes Paclitaxel (Taxol) (6.0 mg/ml) No breakthrough up to 240 minutes Paraplatin (10.0 mg/ml) No breakthrough up to 240 minutes Rituximab (10.0 mg/ml) No breakthrough up to 240 minutes Trisenox (0.1 mg/ml) No breakthrough up to 240 minutes Vincrinstine Sulfate (1.0 mg/ml) No breakthrough up to 240 minutes Carmustine (3.3 mg/ml) ThioTEPA (10.0mg/ml) Tests were carried out by an independent laboratory, under laboratory test conditions. These tests may not adequately replicate any specific condition of use, and because KIMBERLY-CLARK has no detailed knowledge or control over the conditions of end use, any of these data must be advisory only, and KIMBERLY-CLARK must decline any liability. Warning: Do not use this glove when there is a risk of exposure to splash hazards by Carmustine and Thiotepa. We hope this information has been helpful. If we can assist further please let us know at [email protected] Regards Jaime Cassar KIMBERLY-CLARKCategory Manager EMEA - KIMTECH*

Source: http://www.staxs.eu/WSData/WSImages/datasheets/GS-0127_E.pdf