The following data is part of a premarket notification filed by Real Star Medical Technology Co., Ltd. with the FDA for Blue Nitrile Exam Glove, Powder Free.
| Device ID | K210057 |
| 510k Number | K210057 |
| Device Name: | Blue Nitrile Exam Glove, Powder Free |
| Classification | Polymer Patient Examination Glove |
| Applicant | Real Star Medical Technology Co., Ltd. Youdi Industry Park In Dongying District, Dongying, CN 257100 |
| Contact | Nie Jian |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.608,No.738,Shangcheng 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 | 2021-01-11 |
| Decision Date | 2021-03-31 |