Pristine™ Latex Surgical Gloves
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Medispo® PRISTINE™ Features:
Soft and tough: Medispo Pristine™ is our softest formulation glove, and delivers an enhanced level of comfort and tactility. The proprietary formulation of Pristine™ has
been developed by our research and development team over several years and delivers a tough, robust glove with remarkable tensile strength and force at break.
Ideal double-glove companion: Medispo Pristine™ combined with Medispo green under-gloves offer an ideal combination for hole detection in the outer glove. Medispo double gloving system offers world leading protection and optimal comfort levels available. Medispo double gloving system is easy to don yet locks in place and behaves like one glove.
Skin-friendly formulation: Our unique chlorine-free formulation production processes combined with the absence of chemical accelerators known to cause allergic responses mean skin irritations are minimised or eliminated. Tested according to ISO EN 10993.
Complies with the following Standards and Regulations:
Quality: ISO 9001, EN ISO 13485
Compliance EU: CE Mark, MDR, EN 455 1-4, EN ISO 374 1-5
Compliance USA: 510K, ASTM D3577
Environment: EN ISO 14001:2015
Product Information:
| Product Name / Description | Medispo® Pristine, Sterile, Super-Soft, Ergonomic Design, EUSA Mould |
| Latex / Latex-free/ material | Natural Rubber Latex (NRL) |
| Color | White Cream |
| Cuff type | Beaded cuff |
| Accelerators used | ZDEC; CAS No.14324-55-1 |
| Accelerators NOT used | Does not contain: Diphhenylguanidine (DPG), Thiaurams, Mercaptobenzothaiazoles (MBT), P-phenylenediamine (PPD), Zinc dibutyldithiocarbamate (ZDBC), Dialkyl thioureas (DTU) |
| Texture / Grip | Micro textured, calibrated grip, medium |
| Sterile / Non-Sterile / Method | Sterile, E-Beam |
| Powder / Powder-free | Powder-free |
| Design | Anatomical, forward thumb ball, hand specific |
| AQL value | 0.65 (Typically 0.30 – 0.45) |
| 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 2017/745, USA 510k, MDSAP |
| Notified body / Test Laboratories | BSI, SATRA, ARDL, TUV, SGS |
| 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 | Chemical Residuals test data available upon request |
Product Specifacation
| Item No. | MPND55 | MPND60 | MPND65 | MPND70 | MPND75 | MPND80 | MPND85 | MPND890 |
| Size | 5.5 | 6 | 6.5 | 7 | 7.5 | 8 | 8.5 | 9 |
| Length(±5mm) | 280 | 280 | 280 | 285 | 285 | 290 | 290 | 300 |
| Thickness(±0.03mm) | Fingertip: 0.22 Palm: 0.21 Cuff: 0.16 | |||||||
Packing Information
| Pouch material and configuration options | Full-length or square half-fold peel pouch or Paper-Paper packaging | ||
| Packing Quantity | Pouch | Inner box | Shipping Carton |
| 1pair/pouch | 50pairs/box | 200pairs or 400pairs/carton | |
European Representation
| EC Rep & Registration No. | HBM Medical, Coliemore House, 3 Coliemore Road, Dalkey, Co Dublin, Ireland: 653382 |
| EC Rep Contact Details | INFO@4SHBM.COM, Telephone +353 1 582 2308, www.4shbm.com |
| Manufacturer | Guilin HBM Health Protections Inc |
| Address: No.1-2, Shujing East Road, Economic and Technological Development Area, Guilin, China | |
| Email: guilinhbm@hbmchina.com | |
| Web: www.hbmchina.com |
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