The following data is part of a premarket notification filed by Zhonghong Pulin Medical Products Co.,ltd. with the FDA for Nitritec Vinyl Glove Powder Free Blue.
| Device ID | K210460 |
| 510k Number | K210460 |
| Device Name: | NitriTec Vinyl Glove Powder Free Blue |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Zhonghong Pulin Medical Products Co.,Ltd. West Industrial Park, Luannan County Tangshan, CN 063500 |
| Contact | Jia Yongmin |
| 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 | 2021-02-16 |
| Decision Date | 2021-05-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850044566099 | K210460 | 000 |
| 00850044566044 | K210460 | 000 |
| 00850044566020 | K210460 | 000 |
| 00850044566013 | K210460 | 000 |