The following data is part of a premarket notification filed by Jiangxi Hongda Medical Equipment Group Ltd. with the FDA for Medical Pvc Examination Gloves.
| Device ID | K210821 |
| 510k Number | K210821 |
| Device Name: | Medical PVC Examination Gloves |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Jiangxi Hongda Medical Equipment Group Ltd. 39 South Shengli Road, 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 | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-19 |
| Decision Date | 2021-07-09 |