The following data is part of a premarket notification filed by Jiangsu Huayuan Medical Technology Co., Ltd. with the FDA for Nitrile Examination Gloves.
| Device ID | K213044 |
| 510k Number | K213044 |
| Device Name: | Nitrile Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Jiangsu Huayuan Medical Technology Co., Ltd. No. 36 Nanzhuang Road, High-Tech Industrial Development Zone Dongtai City, CN 224299 |
| Contact | Yun Gao |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM. 1801, No. 161 Lujiazui East 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 | 2021-09-22 |
| Decision Date | 2022-01-21 |