Cleared Traditional

Surgical Isolation Gown (K203415) - FDA 510(k) Clearance

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

K203415 · Yanbian Pacific Textile Co., Ltd. · General Hospital
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May 2021
Decision
182d
Days
Class 2
Risk

K203415 is an FDA 510(k) clearance for the Surgical Isolation Gown. Classified as Gown, Isolation, Surgical (product code FYC), Class II - Special Controls.

Submitted by Yanbian Pacific Textile Co., Ltd. (Longjing, CN). The FDA issued a Cleared decision on May 20, 2021 after a review of 182 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 Yanbian Pacific Textile Co., Ltd. devices

Submission Details

510(k) Number K203415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2020
Decision Date May 20, 2021
Days to Decision 182 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
53d slower than avg
Panel avg: 129d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FYC Gown, Isolation, 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

Pacific Fortune Management, Inc.
Rafi Wong

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 - FYC Gown, Isolation, Surgical

All 25
Devices cleared under the same product code (FYC) and FDA review panel - the closest regulatory comparables to K203415.
Disposable Surgical Gowns
K210785 · Chongqing Litai Fashion Group Limited Company · Nov 2021
Isolation Gown AAMI Level 3
K212504 · Kenpax International Limited · Nov 2021
ComfortGuard Surgical Isolation Gown
K210131 · Gri-Alleset, Inc. · Aug 2021
Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back
K202310 · Wildcat Ppe, LLC · Jan 2021
AMD Ritmed AssureWear VersaGown
K190306 · Amd Medicom, Inc. · Jan 2020
SURGICAL ISOLATION GOWN
K171535 · Jingzhou Haixin Green Cross Medical Products Co., Ltd. · Feb 2018