Data / Medical devices / China / Zibo Chengxun Automatic Device Co., Ltd
Zibo Chengxun Automatic Device Co., Ltd: FDA-registered device maker in Zibo Shandong, China, 5 510(k) clearances
Zibo Chengxun Automatic Device Co., Ltd is registered with the FDA (registration 3013576504) in Zibo Shandong, China. It lists 5 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 4, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013576504
- Address
- No. 37 Minan Road, High-tech Industrial, Zibo Shandong, China, 255086
- Owner or operator
- Zibo Chengxun Automatic Device Co., Ltd (10053713)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- January 3, 2017
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| December 4, 2022 | K222815 | Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl | LZA | Substantially Equivalent | Zibo Lanhua Medical Packaging Material Co., Ltd. | accessdata.fda.gov |
| March 22, 2019 | K182554 | Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | He Chuang Plastic & Rubber Co., Ltd. | accessdata.fda.gov |
| May 9, 2017 | K170393 | Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue) | LZA | Substantially Equivalent | Zibo Chengxun Automatic Device Co., Ltd. | accessdata.fda.gov |
| February 15, 2008 | K072227 | VINYL EXAMINATION GLOVE POWDER FREE | LYZ | Substantially Equivalent | Pinnacle Co., Ltd. | accessdata.fda.gov |
| February 8, 2008 | K072228 | SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE) | LYZ | Substantially Equivalent | Pinnacle Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Polymer Patient Examination Glove
- All makers of Medical Glove, Specialty
- All makers of Vinyl Patient Examination Glove
Updated December 4, 2022. 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.