The following data is part of a premarket notification filed by Jiangxi Shengda Medical Technology Co., Ltd. with the FDA for Vinyl Patient Examination Gloves.
| Device ID | K211239 |
| 510k Number | K211239 |
| Device Name: | Vinyl Patient Examination Gloves |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Jiangxi Shengda Medical Technology Co., Ltd. No.25 Factory, Wencheng Block, High-tech Zone, Yushan County Shangrao, CN 334711 |
| Contact | Yun Gao |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, CN 200120 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-26 |
| Decision Date | 2021-07-17 |