The following data is part of a premarket notification filed by Yingxiang Glove Products Co., Ltd. with the FDA for Nitrile Patient Examination Gloves.
| Device ID | K211914 |
| 510k Number | K211914 |
| Device Name: | Nitrile Patient Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Yingxiang Glove Products Co., Ltd. No. 1, Zhendong Industrial Park, Huaqiao Town Huanggang, CN 435400 |
| Contact | Liu Peng |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 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 | 2021-06-21 |
| Decision Date | 2021-10-14 |