Data / Medical devices / China / Better Care Plastic Technology Co., Ltd.
Better Care Plastic Technology Co., Ltd.: FDA-registered device maker in Shenze County Hebei, China, 3 510(k) clearances
Better Care Plastic Technology Co., Ltd. is registered with the FDA (registration 3007842585) in Shenze County Hebei, China. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 7, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007842585
- Address
- Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County Hebei, China, 050000
- Owner or operator
- Better Care Plastic Technology Co., Ltd (10030163)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- August 23, 2010
- 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 | 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 |
|---|---|---|---|---|---|---|
| August 7, 2023 | K223713 | Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | Better Care Plastic Technology Co., Ltd. | accessdata.fda.gov |
| July 27, 2022 | K221269 | Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | Better Care Plastic Technology Co., Ltd. | accessdata.fda.gov |
| August 6, 2010 | K101595 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE | LZA | Substantially Equivalent | Better Care Plastic Technology Cp., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Medical Glove, Specialty
- 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 Polymer Patient Examination Glove
Updated August 7, 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.