Data / Medical devices / China / Zhonghong Pulin Medical Products Co.,ltd.
Zhonghong Pulin Medical Products Co.,ltd.: FDA-registered device maker in Tangshan Hebei, China, 6 510(k) clearances
Zhonghong Pulin Medical Products Co.,ltd. is registered with the FDA (registration 3010201834) in Tangshan Hebei, China. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 30, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010201834
- Address
- West Industrial Park, BDA, Luannan County, Tangshan Hebei, China, 063500
- Owner or operator
- Zhonghong Pulin Medical Products Co.,Ltd. (10051679)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- April 19, 2016
- Registered through
- 2026
- Brand names listed
- NITRILE EXAM GLOVES, Polymer patient examination glove, Polymer patient examination gloveMedical Glove, Specialty, Polymer patient examination gloveMedical Glove, SpecialtyMedical gloves with chemotherapy labeling claims - test for use, nitrile gloves
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | 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, Specification developer | 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 |
|---|---|---|---|---|---|---|
| October 30, 2023 | K231029 | Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl | LZA | Substantially Equivalent | Zhonghong Pulin Medical Products Co., Ltd. | accessdata.fda.gov |
| October 26, 2023 | K230662 | Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs | LZA | Substantially Equivalent | Zhonghong Pulin Medical Products Co., Ltd. | accessdata.fda.gov |
| November 15, 2017 | K171873 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | Zhonghong Pulin Medical Products Co., Ltd. | accessdata.fda.gov |
| March 10, 2016 | K152720 | Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color | LZA | Substantially Equivalent | Xingda Medical Products Co., Ltd. | accessdata.fda.gov |
| March 9, 2016 | K152712 | Nitrile Powder Free Patient Examination Gloves, Blue Color | LZA | Substantially Equivalent | Zhonghong Pulin Medical Products Co., Ltd. | accessdata.fda.gov |
| January 7, 2009 | K082598 | POWDER FREE BLUE PATIENT NITRILE EXAMINATION GLOVE | LZA | Substantially Equivalent | Tangshan Zhonghong Pulin Group Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- 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 October 30, 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.