FDA applicant
Syntex Healthcare Products Co., Ltd.
FDA records 17 decisions for Syntex Healthcare Products Co., Ltd. (Xinji City, Hebei Province, CN) from 2002 to 2024: 17 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and LYY (Latex Patient Examination Glove). Its devices cite 6 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 Syntex Healthcare Products Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Syntex Healthcare 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 “Syntex”
FDA records each applicant name separately; these may or may not be the same firm.