advancetm sterile latex cleanroom gloves
TRANSCRIPT
TM
Sterile
Latex
Cleanroom Gloves
Length 300mm (12")LatexISO Class 4 andEU GMP Grade A CompatibleCategory 3
THE DEFINITIVE LATEXDOUBLE-DONNABLEGLOVE“
BASL
Advance
“
Latex providesexceptional flexibility
and comfort
www.nitritex.comBioClean is a brand ofTM
Double-donnable
Anatomically shaped forenhanced wearer comfort
SPECIFICATIONS PRODUCT CERTIFICATIONSMASTER CODE PACKAGING
One pair per EasyTear™ pouch10 pairs per outer bag Free of Amines & AmidesRecyclable Components
Processed to ensureISO Class 4 & EU GMPGrade A compatibility
EN 374
LEVEL 2
?EN 374
LEVEL 2
0120
MASTER CODE
BASLRE-ORDER CODE SIZE
BASL6.0 6.0
BASL6.5 6.5
BASL7.0 7.0
BASL7.5 7.5
BASL8.0 8.0
BASL8.5 8.5
BASL9.0 9.0
BASL10.0 10.0
PRODUCT ILLUSTRATION
30
0m
m (
12
")
Natural
COLOUR: Natural.
LENGTH: 300mm (12").
MATERIAL: Natural rubber latex.
SHAPE: Hand specific.
SURFACE: Textured.
OTHER FEATURES: Powder-free, beaded cuff, anatomical shape. PROTEIN LEVEL: Less than 50µg/gram.
STERILISATION METHOD: Gamma irradiation.
PACKING: Bagged.
AQL: 1.5 freedom from pinholes (1000ml water test).
PARTICULATES: Processed in a cleanroom environment to ensure compatibility with ISO Class 4 & EU GMP Grade A operating conditions.
PHYSICAL PROPERTIES: Complies with the requirements of the Glove Standard EN420:2003, the European Medical Gloves StandardEN455 (Parts 1, 2 & 3) & EN374-1, 2 & 3:2003.
QUALITY SYSTEMS: Manufactured in a facility holding ISO 9001:2008 and89/686/EEC Article 11b certifications. Processed in an NEBBcertified ISO Class 4 cleanroom environment.
SAMPLING & INSPECTION: In accordance with ISO 2859.
STORAGE INSTRUCTIONS: Store in a dry, cool place (<40°C) away from direct sunlight and fluorescent light.
SHELF LIFE: Five (5) years from date of manufacture.
BAR CODES: Each size carries a unique bar code on the carton (ITF-14) toallow automatic data entry into Stock Control Systems.
LOT NUMBER: This is shown on the sealed pouch and the carton to provide product traceability.
PACKAGING: One cuffed pair per plastic wallet;One wallet per EasyTear™ PE pouch;10 pairs per sealed outer PE bag;20 outer bags per carton liner;One carton liner per carton (200 pairs).
COMPATIBILITY: ISO Class 4 & EU GMP Grade A.
CLASSIFICATION: Category 3 - Complex Design Personal Protective Equipment conforming to PPE Directive 89/686/EEC.
TM
Sterile
Latex
Cleanroom Gloves
Advance
www.nitritex.com
UNITED KINGDOM (Headquarters) [email protected]
MALAYSIA (Manufacturing) [email protected]
CANADA [email protected]
SINGAPORE [email protected]
CHINA [email protected]/81851
ERTIF C ICM AE TT IS OY NS
GSS
ISO9001
U K ASQUALITY
MANAGEMENT
005
ERTIF C ICM AE TT IS OY NS
GSS
ISO
3
4
1 U K ASQUALITY
MANAGEMENT
005
85
GB04/61092
BASL/PDS9