The following data is part of a premarket notification filed by Hebei Kangxida Medical Technology Development Co., Ltd. with the FDA for Nitrile Powder Free Examination Gloves.
| Device ID | K220211 |
| 510k Number | K220211 |
| Device Name: | Nitrile Powder Free Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Hebei Kangxida Medical Technology Development Co., Ltd. No. 5, Chuangye Avenue, Weixian Economic Development Zone Handan, CN 056000 |
| Contact | Xiaomin Liu |
| Correspondent | Bryan Wong PureVision Ai Inc. 111 Town Square Place, Suite 1203 Jersey, NJ 07310 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-26 |
| Decision Date | 2022-05-18 |