Cleared Traditional

Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown (K211765) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 105
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
K212869 · Fugou County Shenxiang Manufacturing Co., Ltd. · Dec 2021
Disposable Surgical Gown
K212925 · Henan Robestain Medical Products Co., Ltd. · Dec 2021
Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE)
K203539 · Unicoglobal, Inc. · Dec 2021
Surgical Gown
K211509 · Hubei Wanli Protective Products Co., Ltd. · Oct 2021
Surgical Gown
K211809 · Wuhan Dymex Healthcare Co., Ltd. · Oct 2021
Surgical Gown
K211077 · Wujiang Tutaike Textiles & Finishing Co., Ltd. · Oct 2021