Cardinal Health Poly Reinforced Surgical Gown— 510(k) K253243

Substantially Equivalent

Cardinal Health 200, LLC

FDA 510(k) clearance K253243 for Cardinal Health Poly Reinforced Surgical Gown, Substantially Equivalent on 2026-04-28. Applicant: Cardinal Health 200, LLC.

Clearance details

Applicant: Cardinal Health 200, LLC
Product code: Code FYA
Advisory panel: General, Plastic Surgery
Date received: 2025-09-29
Decision date: 2026-04-28
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Waukegan, IL, US

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