# Dongguan Shin YI Healthcare Products Factory

- Location (FDA's records): Dong Guan, CN
- FDA decisions: 2 (2021–2023): 2 510(k) clearances
- Product codes: FYA (1), FXX (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Byd Precision Manufacturer Co., Ltd.: 1 (https://510kreport.com/company/byd-precision-manufacturer)

## Recent decisions
- K230610: Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series) (Aug 23, 2023)
- K210372: Disposable Surgical Mask (Jun 7, 2021)

Source page: https://510kreport.com/company/dongguan-shin-yi-healthcare-products-factory