Quality management certification from TUV Sud Thailand- Happy Hands Gloves Co.,Ltd
ISO 13485:2016 (Accredited)
Happy Hands Gloves is a proud to announce that it has received the much coveted EN ISO 13485 accreditation from TUV Sud Thailand in January 2022.
Happy Hands has taken the decision to maintain one certification of ISO 13485 to fulfill its requirements of Medical glove device to the fullest.
Happy Hands has aligned its management and quality requirements to meet the regulatory requirements of the European Union and other countries henceforth you can be assured to receive gloves meeting the highest standards of health and safety.
In the pursuit of providing the best gloves, Happy Hands continually strives to identify weaknesses and areas of improvement to deliver the best gloves to you.
The glove manufacturing requirements of the EN 455 standard and the ASTM standard are as follows (A short summary):
Characteristic | EN 455 | ASTM D 3578 |
Water-tight leakage test | AQL 1.5 | AQL 2.5 |
Tensile Strength | 21 MPa min (Before ageing) | 18 MPa min (Before ageing) |
Elongation | 650% min | 650% min |
Avg Thickness | 0.1 mm | 0.08 mm |
Usage | Hospitals | Food industry/hospital |
Main Characteristic | Best biological barrier protection |