Cardinal Health Poly Reinforced Surgical Gown
K-Number: K253243 · 2026-04-28
ApplicantCardinal Health 200, LLC
Decision Date2026-04-28
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Cardinal Health Poly Reinforced Surgical Gown is a medical device manufactured by Cardinal Health 200, LLC. It received FDA 510(k) clearance on 2026-04-28 under approval number K253243. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Cardinal Health Poly Reinforced Surgical Gown?
Cardinal Health Poly Reinforced Surgical Gown is a medical device that received FDA 510(k) clearance on 2026-04-28. It is manufactured by Cardinal Health 200, LLC. The 510(k) number is K253243.
When was Cardinal Health Poly Reinforced Surgical Gown approved by the FDA?
Cardinal Health Poly Reinforced Surgical Gown received FDA 510(k) clearance on 2026-04-28, under approval number K253243.
What company makes Cardinal Health Poly Reinforced Surgical Gown?
Cardinal Health Poly Reinforced Surgical Gown is manufactured by Cardinal Health 200, LLC.
What is the FDA product code for Cardinal Health Poly Reinforced Surgical Gown?
The FDA product code for Cardinal Health Poly Reinforced Surgical Gown is FYA.
Related Devices (Code: FYA)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.