Material Latex-free, Polyisoprene Color White Cream Cuff type Beaded cuff Accelerators used ZDEC Texture / Grip Micro textured, calibrated grip, medium Sterile / Non-Sterile / Method Sterile,E-Beam / Gamma Powder / Powder-free Powder-free Design Anatomical, forward thumb ball, hand specific AQL value 0.65 International Product Standards EN 455 1-4, EN ISO 374 1-5:2016, EN ISO 21420:2019, ASTM D3577, ASTM D6978, ASTM F739, ISO 10993, AS/NZS 4179, ISO 10282, JIS T9107 Quality/Environmental Standards ISO 9001, ISO 13485:2016, ISO 14001 Shelf Life 3 Years Compliance to regulations EU MDR 2017/745ï¼? USA 510k, MDSAP Notified body/Test Laboratories DEKRA, SATRA, ARDL, BSI PPE compliance / Type PPE Regulation (EU) 2016/425, Type B Biological Evaluation EN 10993, Primary Skin Irritation Test, Dermal Sensitization Assay, Cytotoxicity Test Additional tests Viral Penetration PPE Compliance (ASTM F1671), Chemotherapy Drugs (ASTM D6978), Chemical Residue