Polyisoprene Sensitive Surgical Gloves
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Category:
Medispo® PI Sensitive Features:
Sensitive tactility: Medispo PI Sensitive is designed for surgeons who demand a higher tactile sensitivity.
Skin-friendly formulation: Our unique chlorine-free formulation production processes combined with the absence of chemical accelerators known to cause allergic responses
Easy donning: Skin friendly polymer coated for easy donning even with damp hands saving you time.
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® Polyisoprene Sensitive, Sterile, Super-Soft, Ergonomic Design, EUSA Mould |
| Latex / Latex-free/ material | Latex-free, Polyisoprene |
| 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. | MPSE55 | MPSE60 | MPSE65 | MPSE70 | MPSE75 | MPSE80 | MPSE85 | MPSE90 |
| Size | 5.5 | 6 | 6.5 | 7 | 7.5 | 8 | 8.5 | 9 |
| Length(±5mm) | 290 | 290 | 290 | 290 | 290 | 290 | 290 | 300 |
| Thickness(±0.03mm) | Fingertip: 0.21 Palm: 0.19 Cuff: 0.15 | |||||||
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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