The following data is part of a premarket notification filed by Guang Dong Kingfa Sci. & Tech.co., Ltd. with the FDA for Patient Examination Gloves.
| Device ID | K203593 |
| 510k Number | K203593 |
| Device Name: | Patient Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Guang Dong Kingfa SCI. & TECH.CO., LTD. No. 28 Delong Ave., Shijiao Town, Qingcheng District Qingyuan, CN 511545 |
| Contact | Xiaoge Yu |
| Correspondent | Shelley Li Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 703, 705, Baohua International Plaza, West Guangzhong Road 555, Jingan Shanghai, CN 200071 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-09 |
| Decision Date | 2021-03-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 26973163403231 | K203593 | 000 |
| 06973163402933 | K203593 | 000 |
| 26973163402944 | K203593 | 000 |
| 26973163402951 | K203593 | 000 |
| 26973163402968 | K203593 | 000 |
| 26973163403088 | K203593 | 000 |
| 26973163403095 | K203593 | 000 |
| 26973163403101 | K203593 | 000 |
| 26973163403118 | K203593 | 000 |
| 26973163403200 | K203593 | 000 |
| 26973163403217 | K203593 | 000 |
| 26973163403224 | K203593 | 000 |
| 26975390737714 | K203593 | 000 |