# Winner Industries (Shenzhen) Co., Ltd.

- Location (FDA's records): Ontario, CA
- FDA decisions: 2 (2003–2007): 2 510(k) clearances
- Product codes: FXX (1), FRG (1)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 1 (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
- Crosstex Intl.: 1 (https://510kreport.com/company/crosstex-intl)
- White Knight Healthcare: 1 (https://510kreport.com/company/white-knight-healthcare)
- Winner Medical (Usa), Inc.: 1 (https://510kreport.com/company/winner-medical-usa)
- Medipack Medical Packaging Mfg. Co.: 1 (https://510kreport.com/company/medipack-medical-packaging-mfg)
- Global Healthcare, Inc.: 1 (https://510kreport.com/company/global-healthcare)

## Firms that cite its devices most
- Safe Secure Packaging Co., Ltd.: 1 (https://510kreport.com/company/safe-secure-packaging)

## Its most-cited devices
- K062704: Sterilization Pouch with Indicators (2007), cited by 1

## Recent decisions
- K062704: Sterilization Pouch with Indicators (Jun 8, 2007)
- K023755: Winner Ear Loop Procedure Mask, Tie-on Surgical Mask & Ear Loop Procedure Mask with Shield (Jun 10, 2003)

Source page: https://510kreport.com/company/winner-industries-shenzhen