FDA applicant
Hebei Hongsen Plastics Technology Co, Ltd.
FDA records 5 decisions for Hebei Hongsen Plastics Technology Co, Ltd. (New Milford, NJ) from 2013 to 2017: 5 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and KGO (Surgeon'S Gloves). Its devices cite 5 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 Hongsen Plastics Technology Co, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2017
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2013.
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