The following data is part of a premarket notification filed by Jiangsu Shenglijie Safety Products Co., Ltd with the FDA for Disposable Nitrile Gloves.
| Device ID | K212009 |
| 510k Number | K212009 |
| Device Name: | Disposable Nitrile Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Jiangsu Shenglijie Safety Products Co., Ltd No.88 SI Road Nantong, CN 226401 |
| Contact | Andy Jiang |
| 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 | 2021-06-28 |
| Decision Date | 2021-09-15 |