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 |