Cleared Traditional

K200824 - Cardinal Health SMARTGOWN Breathable Su...

K200824 is the FDA 510(k) clearance for Cardinal Health SMARTGOWN Breathable Su... by Cardinal Health200, LLC. It is a Class 2 General Hospital device (product code FYA) cleared through the Traditional 510(k) pathway after a 121-day FDA review.

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

K200824 is an FDA 510(k) clearance for the Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN.... Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Cardinal Health200, LLC (Waukegan, US). The FDA issued a Cleared decision on July 29, 2020 after a review of 121 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Cardinal Health200, LLC devices

Submission Details

510(k) Number K200824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 129d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FYA Gown, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FYA Gown, Surgical

All 147
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K200824.
Medical Surgical Gowns
K202844 · Beijing Biosis Healing Biolog Ical Technology Co., Ltd. · Jan 2021
Surgical Gown (Sterile), Surgical Gown (Non-sterile)
K202706 · B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. · Dec 2020
Modular Toga
K200977 · Operating Room Innovations, Inc. · Aug 2020
Surgical Gown
K192560 · Shandong Kangli Medical Equipment Technology Co., Ltd. · May 2020
50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown
K192290 · Xuchang Zhengde Environstar Medical Products Co., Ltd. · Apr 2020
Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve
K193327 · Cardinal Health200, LLC · Mar 2020