The following data is part of a premarket notification filed by Nb Medical Co., Ltd with the FDA for Nitrile Examination Gloves.
| Device ID | K220343 |
| 510k Number | K220343 |
| Device Name: | Nitrile Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | NB Medical Co., LTD Tay An Industrial Cluster, Tien Hai Town Tien Hai District, Thai Binh Province, Vietnam Thai Binh Province, VN 410000 |
| Contact | Kecheng Zhou |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161 Lujiazui East Rd.,Pudong Shanghai, CN 200120 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-07 |
| Decision Date | 2022-04-02 |