Cleared Traditional

K211765 - Cardinal Health RoyalSilk Surgical Gown

K211765 is an FDA 510(k) clearance for Cardinal Health RoyalSilk Surgical Gown, manufactured by Cardinal Health, LLC. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K211765 · Cardinal Health, LLC · General Hospital
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Nov 2021
Decision
168d
Days
Class 2
Risk

K211765 is an FDA 510(k) clearance for the Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurs.... Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Cardinal Health, LLC (Waukegan, US). The FDA issued a Cleared decision on November 23, 2021 after a review of 168 days - an extended review cycle.

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 Health, LLC devices

FDA 510(k) Submission Details - K211765

510(k) Number K211765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2021
Decision Date November 23, 2021
Days to Decision 168 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
39d slower than avg
Panel avg: 129d · This submission: 168d
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 162
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K211765.
Disposable Surgical Gown, Disposable Reinforced Surgical Gown
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K211809 · Wuhan Dymex Healthcare Co., Ltd. · Oct 2021
Surgical Gown
K211077 · Wujiang Tutaike Textiles & Finishing Co., Ltd. · Oct 2021