Data / Medical devices / China / Jiangxi Zhonghong Pulin Medical Products Co.,ltd.
Jiangxi Zhonghong Pulin Medical Products Co.,ltd.: FDA-registered device maker in jiujiang Jiangxi, China, 2 510(k) clearances
Jiangxi Zhonghong Pulin Medical Products Co.,ltd. is registered with the FDA (registration 3015142965) in jiujiang Jiangxi, China. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 12, 2021. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3015142965
- Address
- Yinsha Wan Industrial Park,High-tech Industrial Zone of Hukou County, jiujiang Jiangxi, China, 332500
- Owner or operator
- Jiangxi Zhonghong Pulin Medical Products Co.,Ltd. (10059350)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- December 25, 2018
- Registered through
- 2026
- Brand names listed
- Polymer patient examination glove, Vinyl patient exam gloves powder free, nitrile exam glove powder free
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Medical Glove, Specialty | LZC | 1 | Contract manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 12, 2021 | K210723 | Nitrile Patient Examination Glove | LZA | Substantially Equivalent | Jiangxi Zhonghong Pulin Medical Products Co., Ltd. | accessdata.fda.gov |
| October 6, 2018 | K182117 | Vinyl Patient Examination Gloves | LYZ | Substantially Equivalent | Jiangxi Zhonghong Pulin Medical Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Vinyl Patient Examination Glove
- All makers of Medical Glove, Specialty
Updated July 12, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.