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Isofield™ CR++ Sterile Latex Cleanroom Gloves - Grade A/B Compatible

Isofield™ CR++ Sterile Latex Cleanroom Gloves - Grade A/B Compatible

Ref: 30178893

Brand

Full length shoulder protection for GMP Grade A and B, ISO Class 4 Cleanrooms. This ultra long and clean latex glove is triple washed in DI water with a surface smooth enough for double-donning. Every lot of CR++ is tested for endotoxin and has very low levels of detectable protein.

  • Sterile latex Cleanroom gloves
  • 600 mm (24 in.) shoulder length
  • Hand-specific
  • Natural color
  • Textured palm and fingers
  • Beaded cuff
  • Low endotoxin levels
  • Gamma irradiation, minimum 25 kGy
  • Sterility Assurance Level 10-6
  • Protein level less than 50 μg/g
  • IPA resistant ink pouches
  • Acceptable Quality Level (AQL) 0.65
  • Low Particle Count ≥ 0.5 μm (counts/cm2) <1200
  • Type B Chemical Splash Protection (K, P, T)

Technical and Documentation Compliance

  • COA, COC, COI Available for download online
  • QR Code on cartons allows for immediate Document retrieval
  • Chemical innocuousness EN ISO 21420:2020
  • Sizing and dexterity EN ISO 21420:2020 and EN ISO 374-2:2019
  • Air leak and water leak EN ISO 374-2:2019
  • Chemical degradation EN ISO 374-4:2019
  • Chemical permeation EN 16523-1:2015+A1:2018
  • Viral penetration EN 16604:2004
  • Endotoxin test EN 455-3
  • Sterility validation test EN ISO 11137 Part 2:2015
  • EU type certificate EN ISO 374-1:2016+A1:2018 Type B, EN ISO 374-5:2016, EN ISO 374-4:2019
  • Meets The applicable essential health and safety requirements of Annex II of the PPE Regulation (EU) 2016/425 as a Category III product
  • UKCA type certificate EN ISO 374-1:2016+A1:2018 Type B, EN ISO 374-5:2016, EN ISO 374-4:2019
  • Meets The applicable essential health and safety requirements of PPE Regulation (2016/425) as brought into UK law and amended as a Category III product