Active Member
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[China]
Address: Ke Ang Road 3, YangXi Community, JianDe City, ZheJiang Province, China
Contact name:Hong
Jiande Kanghua Medical Devices Co., Ltd |
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Mainly used for wounds cleaning and dressing changing. It is disposable and sterilized, it can reduce the risk of cross-infection effectively. Save time with all in one pack that is ready to use. It’s convenient, easy to use and requires no preparation time. The kit is only for single use.
We do as customer’s requirement for the detailed content and packing method. Therefore, please let us know if you have any special requirements, we are happy to custom the product for you.
| 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 | |
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.
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 |
