Certification: ISO 13485 : 2016
The testing of Latex exam gloves can be divided into the Following steps:
Happy Hands follows the quality and production SOP’s to the fullest and has aligned the management to meet the stringent regulatory requirements of the European Union. You can be assured of receiving the gloves meeting the highest levels of health and safety.
In the pursuit of providing the best gloves, Happy Hands continually strives to identify weaknesses and improvement areas to deliver the best gloves to you. Happy Hands also welcomes quality and improvement inputs from you so you can be assured to suggest and partake.
We welcome factory visits at our plant in Suratthani for you to see the production facility and quality protocols implemented in the factory.
We also have additional certifications needed for product registrations available on request:
- Thai FDA
- CE certificates.
- Technical files, IFU’s and specifications.
- Free Sale certificate available on request.
- EC Rep.
- ISO certificate.
A Quick summary on Glove specifications
| Characteristic | EN 455 | ASTM D 3578 |
|---|---|---|
| Water-tight leakage test | AQL 1.5 | AQL 2.5 |
| Tensile Strength | Force: 7N min (Before ageing) As per ISO 11193-2 and EN 455-2 |
18 MPa min (Before ageing) |
| Elongation | 650% min | 650% min |
| Min Thickness | 0.08 mm | 0.08 mm |
| Usage | Hospitals | Food industry/hospital |
| Main Characteristic | Best biological barrier protection |
