Underglove Latex Surgical Gloves
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Category:
Medispo® Latex Underglove Features:
Perforation detection: Medispo TPC Underglove is an ideal underglove when double-gloving. Designed to interlock with Medispo TPC overglove to deliver an excellent
single glove experience. Our distinct green colour aids in alerting wearers to perforations in the outer glove. Designed to be comfortable and reliable for any type of surgical procedure.
Protection: Computer control and predictive quality analytics (AI) mean that each glove undergoes rigorous quality controls before release. In addition, each glove is
100% air-leaked and visually inspected.
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® Latex Underglove, Sterile, Ergonomic Design, EUSA Mould |
| Latex / Latex-free/ material | Natural Rubber Latex (NRL) |
| Color | Green |
| 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. | MLUG55 | MLUG60 | MLUG65 | MLUG70 | MLUG75 | MLUG80 | MLUG85 | MLUG90 |
| 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: 0.21 Palm: 0.20 Cuff: 0.14 | |||||||
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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