| Glove Material | Nitrile |
| Packaging Data | Triple layer packaging (poly pouch and poly bag plus case liner) 300 pairs per case: one glove pair/ poly wallet & pouch X 30 sealed pouches per PE bag x 10 PE bags per lined carton Packaged in ISO Class 5 Cleanroom |
| Quality & Regulatory Standards | Compliant to these regulatory standards: ISO 9001 ISO 13485 ISO 14001 Compliant to these food handling regulatory standards: FDA 21 CFR 177-2600 FDA 21 CFR 180.22 Commission Regulation (EU) No 10/2011 CE 2797 PPE Category III according to Regulation (EU) 2016/425 EEC EN 16523-1:2015+A1:2018 EN ISO 374-2:2019 EN ISO 374-4:2019 EN ISO 374-5:2016 Bacteria, Fungi, and Virus Protection EN ISO 374-1:2016+A1:2018/ Type B EN ISO 21420:2020 Dexterity Classification: Level 5 Compliant with the REACH regulation RoHS 2011/65/EU Annex II Static Dissipative in Use Tested per ANSI/ ESD SP 15.1 Meets USP <800> Guidelines |
| For Use With (Applications/Environments) | Applications: Medical Device, Microelectronics, Semiconductor, Pharmaceutical, Injection Moulding
Environments: Recommended for use in ISO Class 3 or higher and Grade A/B cleanrooms. Tested against 29 chemicals, 14 chemotherapy drugs and
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| Glove Length (inch/cm) | 12″/30.5 cm |
| Properties | AQL 0.65 Sterile ✓ Hand Specific Pairs ✓ Smooth Grip ✓ Textured Fingertips and Palms ✓ Accelerator-Free1 ✓ Latex-Free ✓ Powder-Free ✓ Silicone-Free ✓ Static Dissipative in Use ✓ Tensile Strength 35 MPa (Target) Ultimate Elongation 600% Sterility Assurance Level (SAL) 10-6 Shelf Life 3 Years |
| Cleanliness Properties (Max Particle Count >0.5µm) | <1200 Particles/cm2 |
| Supporting Documentation | Declaration of Conformity (DoC) and Certificates of Analysis (COA) for every production lot available online at halyardhealth.com/information |
