The following data is part of a premarket notification filed by Jiangxi Hongda Medical Equipment Group Ltd. with the FDA for Medical Nitrile Examination Gloves (power Free, Blue).
| Device ID | K210578 |
| 510k Number | K210578 |
| Device Name: | Medical Nitrile Examination Gloves (Power Free, Blue) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Jiangxi Hongda Medical Equipment Group Ltd. 39 South Shengli RD. Jinxian County Nanchang, CN 331700 |
| Contact | Yang Qinghua |
| Correspondent | Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm. 912 Building #15, XiYueHui, No. 5, YiHe North Rd. FangShan District Beijing, CN 102401 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-26 |
| Decision Date | 2021-07-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 26920756761995 | K210578 | 000 |
| 26920756761919 | K210578 | 000 |
| 26920756761926 | K210578 | 000 |
| 26920756761933 | K210578 | 000 |
| 26920756761940 | K210578 | 000 |
| 26920756761957 | K210578 | 000 |
| 26920756761964 | K210578 | 000 |
| 26920756761971 | K210578 | 000 |
| 26920756761988 | K210578 | 000 |
| 26920756761902 | K210578 | 000 |