Data / Medical devices / China / Zibo Sinocare Plastic Products Co., Ltd.
Zibo Sinocare Plastic Products Co., Ltd.: FDA-registered device maker in ZIBO Shandong, China, 4 510(k) clearances
Zibo Sinocare Plastic Products Co., Ltd. is registered with the FDA (registration 3005060582) in ZIBO Shandong, China. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated February 18, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005060582
- Address
- Lot 5, No. 21 Qingtian Road Qilu Chemical Industrial Park, ZIBO Shandong, China, 255411
- Owner or operator
- ZIBO SINOCARE PLASTIC PRODUCTS CO., LTD. (9071257)
- Roles
- Manufacturer
- First device listed
- November 29, 2007
- Registered through
- 2026
- Brand names listed
- Customer's private label
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Medical Glove, Specialty | LZC | 1 | Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Manufacturer | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | 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 18, 2022 | K213306 | Powder Free Nitrile Examination Gloves, Blue,Test For Use With Chemotherapy Drugs | LZA | Substantially Equivalent | Zibo Sinocare Plastic Products Co., Ltd. | accessdata.fda.gov |
| July 15, 2005 | K051723 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (WHITE, YELLOW) | LYZ | Substantially Equivalent | Zibo Sinocare Plastic Products Co., Ltd. | accessdata.fda.gov |
| June 21, 2005 | K051148 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES | LYZ | Substantially Equivalent | Zibo Sinocare Plastic Products Co., Ltd. | accessdata.fda.gov |
| June 3, 2005 | K051152 | POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) | LYZ | Substantially Equivalent | Zibo Sinocare Plastic Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Vinyl Patient Examination Glove
- All makers of Medical Glove, Specialty
- All makers of Polymer Patient Examination Glove
Updated February 18, 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.