Quality control:
We have established the Quality System and SOP according to ISO 13485 and Medical Device Directive 93/42/EEC. The quality control points during in production process were established to ensure the non-confirming products not to enter into next process or out of factory. On the other hand, the internal audits are implemented and submit some deviation then correction and protection action.
| No. | Test subject | Standard items | Requirements | Results | |
| 1 | 2 | ||||
| 1 |
Components and materials |
4.2.1 | Composed of PVA sponge (dry compression molding) and traction string (Non-absorbent thread). | complied | complied |
| 2 | 4.2.2 |
Made of foam of polymer materials |
complied | complied | |
| 3 | 4.3 | Size:80mm×20mm×15mm | 79.5×19.5×14.7 | 79.6×19.5×14.6 | |
| 5 | Traction String Length>40mm | 160 | 159 | ||
| 6 | 4.4 |
Surface clean, color uniform, free of impurities, burrs, damage and other defects |
complied | complied | |
|
7
|
4.5 |
Traction string be firmly attached,not be torn off in normal use, be able to withstand at least the pull of 5N |
complied | complied | |
Sizes |
|
KHB-452016 |
Small, with airway and strings |
KHB-602016 |
Middle, with airway and strings |
KHB-802016 |
Large, with airway and strings |
KHB-1002016 |
Extra Large, with airway and strings |
- Technology Innovation / Quality and Efficient / Honest and Trustworthy / Customer First.
- 24 hours service online.
- CE, ISO certification are approved.
- Samples are available.
- OEM&ODM are supported.
- Trial orders are welcome.