Cleared Traditional

Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown

K200824 · Cardinal Health200, LLC · General Hospital
Jul 2020
Decision
121d
Days
Class 2
Risk

About This 510(k) Submission

K200824 is an FDA 510(k) clearance for the Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown, a Gown, Surgical (Class II — Special Controls, product code FYA), submitted by Cardinal Health200, LLC (Waukegan, US). The FDA issued a Cleared decision on July 29, 2020, 121 days after receiving the submission on March 30, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K200824 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 2020
Decision Date July 29, 2020
Days to Decision 121 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FYA — Gown, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4040

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