Material Natural rubber latex 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 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 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