Cardinal Health 200, LLC · Class II · Cleared Apr 28, 2026
| K-number | K253243 |
| Device name | Cardinal Health Poly Reinforced Surgical Gown |
| Applicant | Cardinal Health 200, LLC |
| Product code | FYA |
| Device class | Class II |
| Decision date | Apr 28, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 878.4040 |
The Cardinal Health™ Poly Reinforced Surgical Gown is a single-use, disposable protective garment worn by operating room personnel during surgical procedures. It protects both surgical patients and OR personnel from transfer of microorganisms, body fluids, and particulate material, meeting AAMI Level 4 barrier protection requirements. The gown is provided in both sterile and non-sterile forms, with non-sterile versions intended for re-packaging and ethylene oxide sterilization before use.
Not stated in this summary.
The device meets barrier protection requirements of AAMI Level 4 per AAMI PB70 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes. Non-sterile gowns undergo validated ethylene oxide (EO) sterilization in accordance with ISO 11135 standards.
View the full FDA submission: accessdata.fda.gov