FDA applicant
Shanxi Hongjin Plastic Technology Co., Ltd.
FDA records 7 decisions for Shanxi Hongjin Plastic Technology Co., Ltd. (Linfen, CN) from 2018 to 2023: 7 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and LYZ (Vinyl Patient Examination Glove). Since 2016 its 510(k)s took a median of 80 days from receipt to decision, against 92 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 1 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 Shanxi Hongjin Plastic Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2018.
Planning a device like Shanxi Hongjin Plastic Technology 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 “Shanxi”
FDA records each applicant name separately; these may or may not be the same firm.