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Isofield™ CR++ Sterile Latex Cleanroom Gloves - Grade A/B Compatible Product Code.: 30178893
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Isofield™ CR++ Sterile Latex Cleanroom Gloves - Grade A/B Compatible
BIOPHARMA

Product Code. 30178893
8.5
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Size:
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Product Code. 30178893

Brand: Isofield™ 1036085

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Description

Full length shoulder protection for GMP Grade A and B, ISO Class 4 Cleanrooms. This ultra long and clean latex glove is triple washed in DI water with a surface smooth enough for double-donning. Every lot of CR++ is tested for endotoxin and has very low levels of detectable protein.

  • Sterile latex Cleanroom gloves
  • 600 mm (24 in.) shoulder length
  • Hand-specific
  • Natural color
  • Textured palm and fingers
  • Beaded cuff
  • Low endotoxin levels
  • Gamma irradiation, minimum 25 kGy
  • Sterility Assurance Level 10-6
  • Protein level less than 50 μg/g
  • IPA resistant ink pouches
  • Acceptable Quality Level (AQL) 0.65
  • Low Particle Count ≥ 0.5 μm (counts/cm2) <1200
  • Type B Chemical Splash Protection (K, P, T)

Technical and Documentation Compliance

  • COA, COC, COI Available for download online
  • QR Code on cartons allows for immediate Document retrieval
  • 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

Specifications

Chlorinated Yes
Cleanroom Class Class 100 (ISO 5)
Accelerator Free No
AQL 0.65
Color Natural
Disposable Single-use
Exterior Finish Fully Textured
Finger Thickness (English) 7.87 mil
Finger Thickness (Metric) 0.20 mm
Hand Specific
Laboratory/Cleanroom Use Cleanroom
Latex Free No
Material Latex
Palm Thickness (English) 6.69 mil
Palm Thickness (Metric) 0.18 mm
Powdered Powder Free
Product Type Cleanroom Gloves
Size 8.5
Sterility Sterile
Thickness (English) 4.72 mil
Thickness (Metric) 0.12 mm
Grip Design Textured
Packaging Type Individual Pair Packs
Length (English) 24 in.
Length (Metric) 600 mm
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Certificates

Certificates

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1 results found
Lot Number Certificate Type Date Catalog Number
Lot Number240432 Certificate TypeCertificate of Analysis Date31/01/2025 Catalog Number1036085
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