Isofield CRN+

5/5

DATA SHEET
DECLARATION OF CONFORMITY

VALIDATION PACK
DECLARATION OF CONFORMITY
CERTIFICATE FINDER

  • Sterile nitrile Cleanroom gloves
  • Elbow length 400mm (16”)
  • Ambidextrous
  • White colour
  • Textured palm & fingers
  • Beaded cuff
  • Tested against a range of chemotherapy drugs
  • Complies with EU food-grade Regulation (EU) No 10/2011

  • GMP Grade A cleanroom compatible
  • GMP Grade B cleanroom compatible
  • ISO Class 4 cleanroom compatible
  • ISO Class 5 cleanroom compatible
  • Class 10 cleanroom compatible
  • Class 100 cleanroom compatible

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

20240

Small 6.0-6.5 20240S
Medium 7.0-7.5 20240M
Large 8.0-8.5 20240L
XLarge 9.0 20240XL

  • 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

  • One pair per inner PE wallet,
  • One PE wallet per sealed PE pouch,
  • 10 pouches per PE bag,
  • 20 sealed PE bags per lined carton (200 pairs)

  • Manufacture of sterile liquid and lyophilized vials
  • Filtration, filling, stoppering and capping of vials
  • Aseptic compounding and mixing
  • Preparation of sterile emulsions

SKU: 10130-2-2 Category: Tags: , , ,

Description

400mm (16″) Sterile nitrile Cleanroom gloves

Additional information

Cleanroom Grade

,

Length

Material

Sterility

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