FDA applicant
Dongguan Shin YI Healthcare Products Factory
FDA records 2 decisions for Dongguan Shin YI Healthcare Products Factory (Dong Guan, CN) from 2021 to 2023: 2 510(k) clearances. Most are in product codes FYA (Gown, Surgical) and FXX (Mask, Surgical). Its devices cite 1 predicate, 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 Dongguan Shin YI Healthcare Products Factory’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
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