FDA applicant
Tangshan Hongyun Plastic Products Co., Ltd.
FDA records 5 decisions for Tangshan Hongyun Plastic Products Co., Ltd. (Huan Zhong, Roa; Beijing, CN) from 2007 to 2021: 5 510(k) clearances. All are in product code LYZ (Vinyl Patient Examination Glove). Its devices cite 5 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 Tangshan Hongyun Plastic Products Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Tangshan Hongyun Plastic Products Co.…’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 “Tangshan”
FDA records each applicant name separately; these may or may not be the same firm.