# Cardinal Health 200, Inc.

- Location (FDA's records): Waukegan, IL
- FDA decisions: 4 (2006–2026): 4 510(k) clearances
- Names in FDA's records: Cardinal Health 200, Inc. (3); Cardinal Health 200, LLC (1)
- Product codes: FYA (3), KGO (1)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cardinal Health, Inc.: 1 (https://510kreport.com/company/cardinal-health)
- Baxter Healthcare Corp: 1 (https://510kreport.com/company/baxter-healthcare)
- Allegiance Healthcare Corp.: 1 (https://510kreport.com/company/allegiance-healthcare)

## Firms that cite its devices most
- Gri Medical & Electronic Technology Co., Ltd.: 1 (https://510kreport.com/company/gri-medical-electronic-technology)
- Cardinal Health, Inc.: 1 (https://510kreport.com/company/cardinal-health)

## Its most-cited devices
- K151778: Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating (2016), cited by 1
- K061308: Trimax, Model 9515N, Breathable Surgical Gown, Models 3247AN and 9015N and Optima or Surgical Gown, Model 9506N (2006), cited by 1

## Recent decisions
- K253243: Cardinal Health™ Poly Reinforced Surgical Gown (Apr 28, 2026)
- K151778: Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating (Mar 24, 2016)
- K150151: SmartGownTM surgical gown (May 21, 2015)
- K061308: Trimax, Model 9515N, Breathable Surgical Gown, Models 3247AN and 9015N and Optima or Surgical Gown, Model 9506N (Jun 5, 2006)

Source page: https://510kreport.com/company/cardinal-health-200