Cleared Traditional

K220435 - SEJONG Surgical Gown Soft

K220435 is an FDA 510(k) clearance for SEJONG Surgical Gown Soft, manufactured by Sejong Healthcare Co., Ltd.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 361-day FDA review.

K220435 · Sejong Healthcare Co., Ltd. · General Hospital
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Feb 2023
Decision
361d
Days
Class 2
Risk

K220435 is an FDA 510(k) clearance for the SEJONG Surgical Gown Soft. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Sejong Healthcare Co., Ltd. (Paju –Si, KR). The FDA issued a Cleared decision on February 10, 2023 after a review of 361 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Sejong Healthcare Co., Ltd. devices

FDA 510(k) Submission Details - K220435

510(k) Number K220435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2022
Decision Date February 10, 2023
Days to Decision 361 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
232d slower than avg
Panel avg: 129d · This submission: 361d
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 Consultant

K-Bio Solutions
Seohee Kwon

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 165
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K220435.
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