The following data is part of a premarket notification filed by Siyang Threeguard Medical Supplies Co.,ltd. with the FDA for Disposable Nitrile Medical Examination Glove.
| Device ID | K211131 |
| 510k Number | K211131 |
| Device Name: | Disposable Nitrile Medical Examination Glove |
| Classification | Polymer Patient Examination Glove |
| Applicant | Siyang Threeguard Medical Supplies Co.,Ltd. East Of Nanhai Road And South Of Guilin Road, Economic Development Zone, Siyang County Suqian, CN 223799 |
| Contact | Guo Hua |
| 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 | 2021-04-16 |
| Decision Date | 2021-07-29 |