The following data is part of a premarket notification filed by Hengchang (dongying) Medical Technology Co.,ltd. with the FDA for Nitrile Exam Gloves, Powder Free, Blue.
| Device ID | K211699 |
| 510k Number | K211699 |
| Device Name: | Nitrile Exam Gloves, Powder Free, Blue |
| Classification | Polymer Patient Examination Glove |
| Applicant | Hengchang (Dongying) Medical Technology Co.,Ltd. Room 101, Building 2, No.26 Xinghe Road, Niuzhuang Town, Dongying District Dongying, CN |
| Contact | Li Jing |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.161, East Lujiazui 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 | 2021-06-03 |
| Decision Date | 2021-08-20 |