Cleared Traditional

GCI Surgical Gown (K233571) - FDA 510(k) Clearance

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

K233571 · George Courey, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
270d
Days
Class 2
Risk

K233571 is an FDA 510(k) clearance for the GCI Surgical Gown. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by George Courey, Inc. (Laval, CA). The FDA issued a Cleared decision on August 2, 2024 after a review of 270 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 George Courey, Inc. devices

Submission Details

510(k) Number K233571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2023
Decision Date August 02, 2024
Days to Decision 270 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 129d · This submission: 270d
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 Consultant

Emergo by UL
Sarah Fitzgerald

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FYA Gown, Surgical

All 105
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K233571.
Medline Level 4 Surgical Gown with Breathable Sleeves
K242844 · Medline Industries, LP · Feb 2025
Stryker Steri-Shield 8 Surgical Hoods and Togas
K241272 · Stryker Instruments · Oct 2024
ProPel SG3™ Surgical Gown
K241214 · Standard Textile Co., Inc. · Sep 2024
Disposable Surgical Gown
K233068 · Nanning Tecbod Biological Technology Co., Ltd. · Mar 2024
Surgical Gown (40083)
K233183 · Ammex-Weida (Hubei) Health and Safety Products Co., Ltd. · Feb 2024
Skypro, Surgical Gown 6021
K230707 · Skypro Medical Supplies Company · Oct 2023