AT Medical Exam Nitrile Gloves PF Disposable Latex Free | 1 Case | 1000 Gloves

Description

Non-sterile Nitrile gloves.  Formulated with a high level of mechanical strength allowing for a thinner formulation to provide excellent tactile sensitivity and dexterity along with exceptional comfort, fit and feel. High quality manufacturing ensures this glove will hold up for a variety of clinical procedures and general purpose use.
PRODUCT SPECIFICATION
AT Nitrile PF
PRODUCT
Nitrile examination glove
Non-sterile
Powder-free
Textured fingertips
COUNTRY OF ORIGIN
Malaysia
INTENDED USE
This is a disposable device intended for medical purposes that is worn on the examiner?s hand
to prevent contamination between patient and examiner
MATERIAL
Nitrile Butadiene Rubber (NBR). This product does not contain proteins found in natural rubber goods.
OUTER SURFACE
No donning powder used
COMPONENTS
Synthetic rubber (NBR)
Stabilizer (Potassium hydroxide)
Color (Titanium dioxide)
Curing agent (Sulphur)
Accelerators (Zinc diethyl & dibutyl dithio carbamate)
Activator (Zinc oxide)
Surfactant (Alkylbenzene sulfonated salt)
SHAPE
Straight fingers
Thumb and fingers in one plane
Ambidextrous
CUFF
Beaded (rolled rim)
COLOR
Violet blue
SIZES
Small (S), Medium (M), Large (L)
MARKING
Packaging marked to designated size (gloves not marked)
PACKAGING AND LABELING
100 pieces per box, 1000 pieces per case
QUALITY CHARACTERISTICS
All listed standards are used in their latest edition. Current test data on physical properties is
available upon request.
DESCRIPTION
SPECIFICATION
ASSURANCE ACTION
Dimensions
ASTM D 6319 / EN 455
Overall length
240 mm min (S, M, L)
Width
86 mm + 10 mm (S)
95 mm + 10 mm (M)
110 mm + 10 mm (L)
Thickness (single wall)
Finger: 0.05 mm min.
Palm:
0.05 mm min.
Cuff:
0.05 mm min.
Physical properties
ASTM D6319 / EN 455
Tensile strength (before aging)
14 MPa min
(after aging)
14 MPa min
Elongation
(before aging)
500% min
(after aging)
500% min
PERFORMANCE REQUIREMENTS FOR QUALITY CHARACTERISTICS
For reference purpose in accordance with ISO 9001 & 13485 ?Medical Devices Quality Management System?. Demonstrates ability to provide medical devices that consistently meet customer and applicable regulatory requirements.
FINAL GLOVE RELEASE
Assurance action
ASTM D 6319: ?Standard Specification for Nitrile Examination Gloves for Medical Application?
EN455: ?Standard Test Method for The Physical Properties of Medical Disposable Gloves?
Sampling inspection and final release information
Major defects: highest concern non-conformities which prevent correct use of the product. AQL
1.5 (inspection level GI for leaks)
PACKAGING, MARKING, GOOD DELIVERY INSPECTION
Assurance Action
Set-up and patrol inspection at packaging
Supervision of vehicle or vessel loading
GOOD MANUFACTURING PRACTICE
The gloves are manufactured in compliance with ISO 9001, ISO 13485
MICROBIOLOGICAL CLEANLINESS CONTROL
The bioburden of the finished gloves are monitored and recorded. Unusual contaminants are identified. Tests are performed by an approved Institute for Microbiological Control.
CAUTION:
Non-sterile examination gloves are used in a variety of circumstances, including procedures where the surface of the glove contacts wounds, body cavities, or other possible routes of contamination. If conditions warrant, the user may wish to minimize the risk of infection. In this case we recommend the decontamination of the gloves prior to use by disinfectants or other effective methods.
STORAGE
According to ISO 2230 for Vulcanized Rubber
Store in a dry, ventilated area
Avoid direct sunlight, fluorescent lighting, heat and moisture
Do not store above 86° F (30° C) as this will lead to accelerated aging
Long-term storage can result in pleats, stickiness and early aging of the gloves