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Isofield™ Stellar Latex Cleanroom Gloves - Grade A/B Compatible
Description
- offers elbow length protection for GMP Grade A and B cleanrooms
- Sterile latex cleanroom gloves
- 400 mm (16 in.) elbow length
- Hand-specific
- Natural color
- Textured palm and fingers
- Beaded cuff with thicker cuff construction
- Low endotoxin levels
- Gamma irradiation, minimum 25 kGy
- Sterility Assurance Level 10-6
- Food safe; complies with limits established under Regulation (EU) No 10/2011
- Protein level less than 50 μg/g
- Double donnable
- IPA resistant ink pouches
- Acceptable Quality Level (AQL) 0.65
- Low Particle Count ≥ 0.5μm (counts/cm2) <1200
- Type B Chemical Splash Protection
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 and USP
- 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
- UKCA type certificate EN ISO 374-1:2016+A1:2018 Type B, EN ISO 374-5:2016, EN ISO 374-4:2019
Specifications
Specifications
| Certifications/Compliance | EN ISO 21420:2020, EN ISO 374-1:2016+A1:2018 Type B, EN ISO 374-5:2016, EN 455-2:2015 |
| Certifications/Compliance (Europe) | CE Marked; PPE Regulation (EU) 2016/425; Medical Device Regulation (EU) 2017/745 |
| Chemotherapeutic Rated | Yes |
| Chlorinated | Yes |
| Cleanroom Class | Class 100 (ISO 5) |
| Accelerator Free | No |
| AQL | 0.65 |
| Color | Natural |
| Disposable | Single-use |
| Exterior Finish | Fully Textured |
| Show More |
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