Nitrile Powder-Free Examination Gloves · 2020-02-21 · Nitrile Powder-Free Examination Gloves NON-STERILE Along with the durability and strength of nitrile, these gloves were tested

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) Min. ≥ 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 5973

100 Gloves per Boxand

1000 Gloves per Case

Medium 5951 5974

Large 5950 5975

X-Large 5949 5976

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.