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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
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Código de producto. 30178835
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Tamaño:
10
6
6.5
7
7,5
8
8,5
9
Tamaño de la unidad:
200 pares
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Código de producto. 30178835

Marca: Isofield™ 2044060

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Descripción

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

Especificaciones

Cleanroom Class Class 100 (ISO 5)
Accelerator Free Sí
AQL 0.65
Color Blanco
Desechables Single-use
Acabado exterior Totalmente texturizados
Finger Thickness (English) 6.69 mil
Finger Thickness (Metric) 0.17 mm
Hand Específico
Latex Free Sí
Material Nitrilo
Palm Thickness (English) 4.33 mil
Palm Thickness (Metric) 0.11 mm
En polvo sin polvo
Tipo de producto Cleanroom Gloves
Tamaño 6
Esterilidad Estéril
Grosor (imperial) 3.54 mil
Grosor (métrico) 0.09 mm
Longitud (imperial) 16 in
Longitud (métrico) 400 mm
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