The following data is part of a premarket notification filed by Shandong Maida Medical Technology Co.,ltd. with the FDA for Disposable Nitrile Powder-free Examination Gloves.
| Device ID | K221192 |
| 510k Number | K221192 |
| Device Name: | Disposable Nitrile Powder-Free Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Shandong Maida Medical Technology Co.,Ltd. Room 102, Eastern Building, No.166 South 1st Road, Development Zone Dongying, CN 257000 |
| Contact | Kitty Xu |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room608,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 | 2022-04-25 |
| Decision Date | 2022-06-22 |