FDA 510(k) clearance · back to tracker
Cardinal Health Poly Reinforced Surgical Gown
Cardinal Health 200, LLC cleared K253243 on 2026-04-28, decision: substantially equivalent
K-number
K253243
Sponsor
Cardinal Health 200, LLC
Device
Cardinal Health Poly Reinforced Surgical Gown
Class
Class II
Decision
Substantially Equivalent
Decision date
2026-04-28
Product code
FYA
Advisory committee
General, Plastic Surgery
Medical specialty
General, Plastic Surgery
Regulation number
878.4040
Official FDA record
Open K253243on accessdata.fda.gov →
FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.
openFDA JSON
Raw record →
Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.
Use this as a predicate
Drop K253243 into Compass and start a substantial-equivalence draft.
Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.
Try the sandboxSource
Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.