FDA applicant
Zibo Hongye Shangqin Plastic Rubbert Co, Ltd.
FDA records 2 decisions for Zibo Hongye Shangqin Plastic Rubbert Co, Ltd. (Beijing, CN) from 2007 to 2008: 2 510(k) clearances. All are in product code LYZ (Vinyl Patient Examination Glove). Its devices cite 2 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 Hongye Shangqin Plastic Rubbert Co, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2008
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Zibo Hongye Shangqin Plastic Rubbert…’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.