FDA applicant
Zibo Sinocare Plastic Products Co., Ltd.
FDA records 4 decisions for Zibo Sinocare Plastic Products Co., Ltd. (Beijing, CN) from 2005 to 2022: 4 510(k) clearances. Most are in product codes LYZ (Vinyl Patient Examination Glove) and LZA (Polymer Patient Examination Glove). Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Zibo Sinocare Plastic Products Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Zibo Sinocare Plastic Products Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Zibo”
FDA records each applicant name separately; these may or may not be the same firm.