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

• 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