# Shandong Zhushi Pharmaceutical Group Co., Ltd.

- Location (FDA's records): Heze, CN
- FDA decisions: 8 (2021–2024): 8 510(k) clearances
- Product codes: FXX (2), FPA (1), FYA (1), FMF (1), LZA (1), FLL (1), LYZ (1)
- 510(k) review time since 2016: median 162 days, against 163 for FDA's reviews in the same codes and years (2 of 8 faster)
- Predicates its devices cite: 8 (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
- Jiangxi Hongda Medical Equipment Group, Ltd.: 1 (https://510kreport.com/company/jiangxi-hongda-medical-equipment-group)
- Cardinal Health200, LLC: 1 (https://510kreport.com/company/cardinal-health200)
- Xiantao Rayxin Medical Products Co., Ltd.: 1 (https://510kreport.com/company/xiantao-rayxin-medical-products)
- Shanghai Kohope Medical Devices Co., Ltd.: 1 (https://510kreport.com/company/shanghai-kohope-medical-devices)
- Ever Global (Vietnam) Enterprise Corporation: 1 (https://510kreport.com/company/ever-global-vietnam-enterprise)
- Shenzhen Changkun Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-changkun-technology)
- Guangdong Haiou Medical Apparatus Co., Ltd.: 1 (https://510kreport.com/company/guangdong-haiou-medical-apparatus)
- Hebei Hongtai Plastic Products Co., Ltd.: 1 (https://510kreport.com/company/hebei-hongtai-plastic-products)

## Recent decisions
- K232475: Disposable infusion set with needle (May 10, 2024)
- K212033: Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle (Aug 17, 2022)
- K210510: Disposable Surgical Gown (Aug 12, 2021)
- K210643: Disposable Surgical Face Mask (Aug 4, 2021)
- K210409: Disposable Surgical Face Mask (Jul 28, 2021)
- K203454: Infrared Thermometer (Apr 29, 2021)
- K203436: Disposable Nitrile Examination Gloves (Apr 28, 2021)
- K203439: Disposable Vinyl Examination Gloves (Feb 26, 2021)

Source page: https://510kreport.com/company/shandong-zhushi-pharmaceutical-group