Data / Medical devices / China / Xinwei (shandong) Plastic And Rubber Products Co Ltd.
Xinwei (shandong) Plastic And Rubber Products Co Ltd.: FDA-registered device maker in Zibo Shandong, China, 5 510(k) clearances
Xinwei (shandong) Plastic And Rubber Products Co Ltd. is registered with the FDA (registration 3028162329) in Zibo Shandong, China. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated November 28, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3028162329
- Address
- 41 Shuangshan Road Boshan District, Zibo Shandong, China, 255000
- Owner or operator
- Xinwei (Shandong) Plastic and Rubber Products Co Ltd. (10088635)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- September 11, 2023
- Registered through
- 2026
- Brand names listed
- Patient Nitrile Examination Gloves, Powder Free, Non-Sterile, Powder Free Nitrile Examination Glove , Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl, Synthetic Nitrile Patient Exam Gloves, Powder Free, Tested for Use w/Chemotherapy Drug, Synthetic Nitrile Patient Examination Gloves, Powder Free, and Tested for Use with Chemotherapy Drugs
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 |
|---|---|---|---|---|---|---|
| November 28, 2023 | K232252 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange) | LZA | Substantially Equivalent | Dehai (Shandong) Medical Gloves, Co., Ltd. | accessdata.fda.gov |
| August 25, 2017 | K170136 | Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | Shandong Feiyang Professional Gloves Co., Ltd. | accessdata.fda.gov |
| November 21, 2016 | K161944 | Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | Shandong Baisheng Medical Products Co., Ltd. | accessdata.fda.gov |
| February 28, 2013 | K123869 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES | LZA | Substantially Equivalent | Dehai (Shandong) Medical Gloves, Co., Ltd. | accessdata.fda.gov |
| October 16, 2012 | K121992 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR | LZA | Substantially Equivalent | Xinwei (Shandong) Plastic and Rubber Products Co., | 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 November 28, 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.