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
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
