nitrile powder-free examination gloves - medisca hd... · 2020. 1. 14. · • meets astm d5151...
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Nitrile Powder-Free Examination GlovesNON-STERILE
Along with the durability and strength of nitrile, these gloves were tested using ASTM standards for permeation against 65 chemotherapy drugs and chemicals.* Their ambidextrous design with textured fingertips and beaded cuff ensure a sturdy, comfortable product, combining safety and tactile sensitivity. Their silky smooth finish and polyurethane coating makes them extra comfortable to wear and easy to don and remove. Safe-Sense gloves are made from durable nitrile, thus eliminating Type 1 allergic reactions associated with natural rubber.
Trust Safe-Sense to provide the protection you need. These gloves are great for all non-hazardous and hazardous daily compounding activities.
FEATURES:• Tested using ASTM standards for permeation against
65 chemotherapy drugs and chemicals*
• Not made with natural rubber latex – Eliminates Type 1 allergic reaction associated with natural rubber
• Produced with distilled water for a silky feeling
USE THESE GLOVES FOR:• Hazardous drug compounding
• Non-hazardous drug compounding
CONFORMS TO ASTM D6978 – A REQUIREMENT FOR USP <800>
PHYSICAL SPECIFICATIONS:LENGTH: ≥ 9" (≥ 230 mm)
MATERIAL: Nitrile, Powder-Free
THICKNESS: 5 mil
PROTEIN LEVEL: Proteins not detected
DESIGN: Ambidextrous; beaded cuff to reduce roll down and ripping
TEXTURE: Textured fingertips for exceptional grip and sensitivity
COLORS: Blue or black
We Shield You™
LABORATORYPHARMACYCOMPOUNDING FOODMEDICAL
Single Use
Not Made With Natural Rubber Latex
Chemo Tested
Fingertips Ambidextrous
MEETS ALL REQUIRED QUALITY STANDARDS:• Physical properties comply with ASTM D6319 standard specification for
nitrile examination gloves for medical application and EN 455 European medical glove standards for single use
• Complies with European glove standards EN 374, EN 420 and EN 455
• Meets ASTM D5151 freedom from holes / AQL 1.5
• Meets ASTM D6978 resistance to permeation by chemotherapy drugs
• Meets FDA requirements for food handling applications
• Manufactured in an ISO 13485 certified facility
• FDA 510(K) available
VALUES SMALL MEDIUM LARGE X-LARGE MEETS STANDARD
Glove Length (in. / mm) Minimum ≥ 9" (≥ 230 mm) ASTM D6319 /
EN 455 / EN 420Palm Width (mm) 80 +/- 10 mm 95 +/- 10 mm 110 +/- 10 mm 120 +/- 10 mm
Finger Thickness (mm) 0.13 mm
ASTM D6319Palm Thickness (mm) 0.10 mm
Cuff Thickness (mm) 0.09 mm
Freedom from Holes AQL 1.5 ASTM D5151 / EN 455-1 / EN 374-2
BEFORE AGING AFTER AGING
Ultimate Tensile Strength(Psi) (MPa) 2072 Psi / ≥ 14 MPa ASTM D6319 /
EN 455-4
Elongation at Break (%) ≥ 500% ≥ 400% ASTM D6319 / EN 455-4
Force at Break (Newtons) ≥ 6 N EN 455-2
Manufacturing / QMS Audit Standards ISO 13485, ISO 9001, CE Certified Factory
Other Regulatory / StandardsCompliance
FDA 510(K), Medical Examination Grade, FDA 21 CFR 177.2600, ASTM F1671 Viral Penetration,Sampling procedures according to ISO 2859
Chemotherapy Drugs Tested *Carmustine (BCNU), Cisplatin, Cyclophosphamide (Cytoxan), Dacarbazine (DTIC), Doxorubicin
Hydrochloride, Etoposide (Toposar), Fluorouracil, Methotrexate, Mitomycin C, Paclitaxel (Taxol), Thiotepa, Vincristine Sulfate and more.
ASTM D6978
SHELF LIFE:• 5 Years
* Full listing of chemotherapy tested drugs available. Speak to your sales representative for more information.
RE-ORDER CODES:
MEDISCA PHARMACEUTIQUE INC.Saint-Laurent, QC H4R 2L8 Canada 1-800-665-6334
MEDISCA INC.Plattsburgh, NY, 12901 USA 1-800-932-1039
MANUFACTURED FOR:
STORAGE: • Store in a cool, dry place, between 10° – 40°C (50° – 104°F)
SIZE BLUE BLACK PACK
Small 5952-01 5973-01
100 Gloves / BoxMedium 5951-01 5974-01
Large 5950-01 5975-01
X-Large 5949-01 5976-01
CAUTION:• Change glove immediately if damaged or punctured.
• Gloves used for protection against chemotherapy drugs must be selected specifically for the type of chemicals used.*
• No glove provides complete protection against chemicals. Users must test the gloves against the particular chemicals and environments in which they will be used.
• Neither this document nor any other statement made herein or on behalf of MEDISCA should be construed as a warranty of merchantability or that any MEDISCA product is fit for a particular purpose. MEDISCA assumes no responsibility for the suitability or adequacy of a user’s selection of gloves for a specific application and should be at the sole discretion of the user.
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