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Isofield™ NS400 Non-Sterile Nitrile Cleanroom Gloves - ISO Class 4/5 Compatible
BIOPHARMA

Product Code. 30178854
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This item is not returnable. View return policy

Non-sterile nitrile extended cuff offers elbow length protection for ISO class 4 cleanrooms and above. Triple washed in DI water, the low LPC, food grade NS400 is Chemo tested to ASTM D 6978-05, has low endotoxin and is smooth enough for double donning with a textured palm/fingers for added grip.

  • Non-sterile nitrile Cleanroom gloves
  • 400 mm (16 in.) elbow length
  • Ambidextrous
  • White color
  • Textured palm and fingers
  • Beaded cuff
  • Low endotoxin levels
  • Tested against a range of chemotherapy drugs
  • Complies with EU food grade regulation (EU) No 10/2011
  • IPA resistant ink pouches
  • Acceptable Quality Level (AQL) 1.5
  • Low Particle Count ≥ 0.5 μm (counts/cm2) <1800
  • Type B Chemical Splash Protection (K, P, T)

Technical and Documentation Compliance

  • COA, COC Available for download online
  • 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
  • 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
  • Tested against Chemotherapy to ASTM D 6978-05

Specifications

Cleanroom Class Class 100 (ISO 5)
Accelerator Free No
AQL 1.5
Color White
Disposable Single-use
Exterior Finish Fully Textured
Finger Thickness (English) 6.69 mil
Finger Thickness (Metric) 0.17 mm
Hand Ambidextrous
Latex Free Yes
Material Nitrile
Palm Thickness (English) 4.33 mil
Palm Thickness (Metric) 0.11 mm
Powdered Powder Free
Product Type Controlled Environment Gloves
Size Large
Sterility Non-sterile
Thickness (English) 3.54 mil
Thickness (Metric) 0.09 mm
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