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
