The following data is part of a premarket notification filed by Jiangxi Handspro Products Solutions Co., Ltd. with the FDA for Disposable Nitrile Examination Gloves.
| Device ID | K223004 |
| 510k Number | K223004 |
| Device Name: | Disposable Nitrile Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Jiangxi Handspro Products Solutions CO., LTD. Chuangye Avenue, Fenglin Industrial Zone Of Dean County, Jiujiang, CN 330406 |
| Contact | Jun Yin |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161, East Lujiazui 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 | 2022-09-29 |
| Decision Date | 2022-12-04 |