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  6. Isofield™ Eclipse Sterile Nitrile Cleanroom Gloves - Grade A/B Compatible

Isofield™ Eclipse Sterile Nitrile Cleanroom Gloves - Grade A/B Compatible
BIOPHARMA

Product Code. 30178903
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Size:
6
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10
This item is not returnable. View return policy
This item is not returnable. View return policy

Description

This sterile nitrile extended cuff with arm-lock technology offers elbow length protection for GMP Grade A and B Cleanrooms. Triple washed in DI water, the low endotoxin Isofield Eclipse has been tested for chemotherapy against ASTM D 6978-05, is accelerator free, and anti-static.

  • Sterile nitrile Cleanroom gloves
  • 400 mm (16 in.) elbow length
  • Hand-specific
  • White color
  • Textured palm and fingers
  • Beaded cuff
  • Low endotoxin levels
  • Gamma irradiation, minimum 25 kGy
  • Sterility Assurance Level 10-6
  • Tested against a range of chemotherapy drugs
  • IPA resistant ink pouches
  • Acceptable Quality Level (AQL) 0.65
  • Low Particle Count ≥ 0.5μm (counts/cm2) <950
  • Type B Chemical Splash Protection (K, P, T)

Technical and Documentation Compliance

  • COA, COC,COI 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
  • 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
  • Tested against Chemotherapy to ASTM D 6978-05

Specifications

Cleanroom Class Class 100 (ISO 5)
Accelerator Free Yes
AQL 0.65
Color White
Disposable Single-use
Exterior Finish Fully Textured
Finger Thickness (English) 6.69 mil
Finger Thickness (Metric) 0.17 mm
Hand Specific
Latex Free Yes
Material Nitrile
Palm Thickness (English) 4.33 mil
Palm Thickness (Metric) 0.11 mm
Powdered Powder Free
Product Type Cleanroom Gloves
Size 10
Sterility Sterile
Thickness (English) 3.54 mil
Thickness (Metric) 0.09 mm
Length (English) 16 in.
Length (Metric) 400 mm
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