Data / Medical devices / China / Lingshi Hongruida Health Protection Technology Co., Ltd.
Lingshi Hongruida Health Protection Technology Co., Ltd.: FDA-registered device maker in Jinzhong City Shanxi, China, 5 510(k) clearances
Lingshi Hongruida Health Protection Technology Co., Ltd. is registered with the FDA (registration 3020984755) in Jinzhong City Shanxi, China. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated February 29, 2024. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3020984755
- Address
- Yangjiayuan, Liangdu Town, Lingshi County, Jinzhong City Shanxi, China, 031300
- Owner or operator
- Lingshi Hongruida Health Protection Technology Co., Ltd. (10082924)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 13, 2023
- Registered through
- 2027
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 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 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 |
|---|---|---|---|---|---|---|
| February 29, 2024 | K240051 | Powder Free Nitrile Examination Gloves (Blue), Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs | LZA | Substantially Equivalent | Lingshi Hongruida Health Protection Technology Co., Ltd. | accessdata.fda.gov |
| November 3, 2023 | K232266 | Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | Better Care Plastic Technology Co., Ltd. | accessdata.fda.gov |
| August 16, 2022 | K213937 | Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution | LZA | Substantially Equivalent | O&M Halyard, Inc. | 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 |
| April 28, 2006 | K060147 | POWDER FREE NITRILE EXAMINATION GLOVES, BLUE | LZA | Substantially Equivalent | Hongye Plastic Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Medical Glove, Specialty
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
Updated February 29, 2024. 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.