FDA applicant
Hebei Titans Hongsen Medical Technology Co., Ltd.
FDA records 7 decisions for Hebei Titans Hongsen Medical Technology Co., Ltd. (Xingtai, CN) from 2018 to 2024: 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 85 days from receipt to decision, against 92 for FDA’s reviews in the same codes and years. Its devices cite 8 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 Hebei Titans Hongsen Medical Technology 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 2018.
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