The following data is part of a premarket notification filed by Nanjing Universal Medical Equipment Co., Ltd with the FDA for Disposable Medical Nitrile Examination Gloves.
| Device ID | K220561 |
| 510k Number | K220561 |
| Device Name: | Disposable Medical Nitrile Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Nanjing Universal Medical Equipment Co., Ltd 288 Qinhuai Avenue, Yongyang Street, Lishui District Nanjing, CN 210000 |
| Contact | Jerry Gao |
| Correspondent | Jerry Gao Nanjing Universal Medical Equipment Co., Ltd 288 Qinhuai Avenue, Yongyang Street, Lishui District Nanjing, CN 210000 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-28 |
| Decision Date | 2022-04-14 |