The following data is part of a premarket notification filed by Changzhou Xingrong Medical Technology Co. Ltd with the FDA for Zinrom Nitrile Examination Gloves.
| Device ID | K211719 |
| 510k Number | K211719 |
| Device Name: | ZinRom Nitrile Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Changzhou Xingrong Medical Technology Co. LTD No. 528, Daqiaotou, Chaoyang Cunwei, Hengshanqiao Town, Economic Develop Changzhou, CN 213118 |
| Contact | Ray Lei |
| Correspondent | Amber Pang Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 1308, Baohua International Plaza, West Guangzhong Road 555, Jingan Shanghai, CN 200071 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-04 |
| Decision Date | 2021-10-06 |