Obstetrics Latex Surgical Gloves
Keywords:
Category:
Medispo® Obstetrics Features:
Comfort, dexterity and protection: Comfortable and more protective, designed specifically for gynecology: elongated sterilized gloves, suitable for gynecological and other surgeries, providing more protection. Comfortable and flexible.
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.
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.
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® Obstetrics, Sterile, Hand Specific |
| Latex / Latex-free/ 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 |
| 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 | 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 |
Product Specifacation
| Item No. | MOSG55 | MOSG60 | MOSG65 | MOSG70 | MOSG75 | MOSG80 | MOSG85 | MOSG90 |
| Size | 5.5# | 6.0# | 6.5# | 7.0# | 7.5# | 8.0# | 8.5# | 9.0# |
| Length(±5mm) | ≥430 | ≥430 | ≥430 | ≥430 | ≥430 | ≥430 | ≥430 | ≥430 |
| Thickness(±0.03mm) | Fingertip: 0.22 Palm: 0.21 Cuff: 0.16 | |||||||
Packing Information
| Pouch material | Long or square plastic peel pouch;Paper pouch | ||
| 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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Address: No. 1-2, Shuijing East Road, Economic Development Zone, Guilin City
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