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| Brand Name : | KangHua |
| Model Number : | KHB-452015 KHB-602015 KHB-802015 KHB-1002015 |
| Price : | Negotiation |
| Payment Terms : | L/C, T/T, Western Union |
| Supply Ability : | 10000 packs per month |
| Delivery Time : | 5-8 working days |
| Certification : | CE,MA CNAS,ISO13485,etc... |
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 |
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