The following data is part of a premarket notification filed by Fujian Ercon Medical Management Co., Ltd. with the FDA for Disposable Nitrile Gloves.
| Device ID | K210276 |
| 510k Number | K210276 |
| Device Name: | Disposable Nitrile Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Fujian Ercon Medical Management Co., Ltd. Unit 701, Xinyi International Center, No.3911 Huandao East Road, Siming District Xiamen, CN 361000 |
| Contact | Lin Ruijin |
| 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 | 2021-02-01 |
| Decision Date | 2021-04-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16973847530003 | K210276 | 000 |