Cleared Traditional

K230838 - Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets

K230838 is an FDA 510(k) clearance for Cardinal Health SmartGown EDGE Breathab..., manufactured by Cardinal Health200, LLC. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K230838 · Cardinal Health200, LLC · General Hospital
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Jul 2023
Decision
122d
Days
Class 2
Risk

K230838 is an FDA 510(k) clearance for the Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instru.... 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 27, 2023 after a review of 122 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

FDA 510(k) Submission Details - K230838

510(k) Number K230838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2023
Decision Date July 27, 2023
Days to Decision 122 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
7d faster than avg
Panel avg: 129d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FYA Device Classification - Class 2, Special Controls

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 212
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K230838.
Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series)
K230610 · Dongguan Shin YI Healthcare Products Factory · Aug 2023
Surgical Gown (S,M,L,XL,XXL,XXXL)
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Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)
K230577 · Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi · Aug 2023
Surgical Gown
K222999 · Hubei Woozon Healthcare Co., Ltd. · Jun 2023
High Protection Surgical Gown
K222456 · 3A Medical Products Co., Ltd. · Mar 2023
Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)
K223401 · Xiamen Probtain Medical Techology Co., Ltd. · Mar 2023