DATA SHEET
DECLARATION OF CONFORMITY
VALIDATION PACK
DECLARATION OF CONFORMITY
CERTIFICATE FINDER
  • Sterile latex Cleanroom gloves
  • 600mm (24”) shoulder length
  • Hand-specific
  • Textured palm and fingers
  • Natural colour
  • Beaded cuff
  • Low endotoxin levels
  • Gamma irradiation, minimum 25kGy
  • Sterility Assurance Level 10-6
  • Protein level less than 50μg/g
  • IPA resistant ink pouches
  • GMP Grade A cleanroom
  • GMP Grade B cleanroom
  • ISO Class 4 cleanroom
  • ISO Class 5 cleanroom
  • Class 10 cleanroom
  • Class 100 cleanroom
Manufactured in a facility operating under ISO 9001 quality management system Processed in a NEBB certified ISO Class 5 Cleanroom Physical properties comply with European medical glove standard EN455-2:2015 Sterilization: Gamma irradiation, EN ISO 11137 Part 2:2015

10360

Size 6.5 1036065
Size 7.0 1036070
Size 7.5 1036075
Size 8.0 1036080
Size 8.5 1036085
Size 9.0 1036090
  • Shelf Life 
  • Three (3) years from date of manufacture
  • Storage
  • Store in a dry, cool place (<40°C) away from direct sunlight
  • Do not expose open cartons to prolonged direct fluorescent light
  • 1 pair per inner PE wallet,
  • 1 PE wallet per sealed PE pouch, 10 pouches per PE bag,
  • 10 sealed PE bags per lined carton (100 pairs)
  • Loading and unloading of lyophilizer or depyrogenation tunnel
  • Blending granulates and powders
  • Transfer of partially closed containers used in freeze-drying
  • Sterile lyophilization of parenteral drug products