Data / Medical devices / China / Shanxi Hongjin Plastic Technology Co., Ltd
Shanxi Hongjin Plastic Technology Co., Ltd: FDA-registered device maker in Linfen Shanxi, China, 7 510(k) clearances
Shanxi Hongjin Plastic Technology Co., Ltd is registered with the FDA (registration 3013565389) in Linfen Shanxi, China. It lists 5 device types. The FDA files 7 510(k) clearances under its listings, the newest dated August 31, 2023. Registered through 2026. FDA data exported November 2, 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
- 3013565389
- Address
- Coal Bed Gas Industrial Zone, Qu'e Town Daning county, Linfen Shanxi, China, 042300
- Owner or operator
- Shanxi Hongjin Plastic Technology Co., LTD (10054957)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- May 17, 2017
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| August 31, 2023 | K232353 | Powder Free Nitrile Examination Gloves (Black) | LZA | Substantially Equivalent | Shanxi Hongjin Plastic Technology Co., Ltd. | accessdata.fda.gov |
| June 9, 2023 | K230779 | Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | Shanxi Hongjin Plastic Technology Co., Ltd. | accessdata.fda.gov |
| March 26, 2022 | K220229 | Powder Free Nitrile Examination Gloves, Orange | LZA | Substantially Equivalent | Shanxi Hongjin Plastic Technology Co., Ltd. | accessdata.fda.gov |
| October 27, 2021 | K211604 | Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | Shanxi Hongjin Plastic Technology Co., Ltd. | accessdata.fda.gov |
| November 7, 2018 | K180381 | Powder Free Vinyl Patient Examination Gloves | LYZ | Substantially Equivalent | Shanxi Hongjin Plastic Technology Co., Ltd. | accessdata.fda.gov |
| June 12, 2018 | K180260 | Powder Free Vinyl Patient Examination Gloves (Yellow, White) | LYZ | Substantially Equivalent | Shanxi Hongjin Plastic Technology Co., Ltd. | accessdata.fda.gov |
| September 20, 2004 | K042378 | NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE | LZA | Substantially Equivalent | Shijiazhuang Tillotson Rubber Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Vinyl Patient Examination Glove
- All makers of Polymer Patient Examination Glove
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Medical Glove, Specialty
Updated August 31, 2023. 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.