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Isofield™ Stellar Latex Cleanroom Gloves - Grade A/B Compatible

Product Code. 32016138
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32016138 10
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32016127 7.5
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32016129 8.5
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Product Code. 32016138 Supplier Isofield™ Supplier No. 10440100
 Restricted Item
Estimated Shipment: 10-09-2026
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Ultra clean hand-specific glove has an extended cuff, is triple washed in deionized water, and is suitable for the safe handling of food.

  • 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

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
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) 0.17 mm
Powdered Powder Free
Product Type Cleanroom Gloves
Size 10
Sterility Sterile
Thickness (English) 4.33 mil
Thickness (Metric) 0.11 mm
Glove Cuff Style Beaded
Grip Design Textured
Manufacturing/QMS Audit Standards ISO 9001
Model Stellar
Packaging Type Individually Packed
Length (English) 16 in.
Length (Metric) 400 mm
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