Cleared Traditional

K120192 - DISPOSABLE SURGICAL GOWNS

K120192 is an FDA 510(k) clearance for DISPOSABLE SURGICAL GOWNS, manufactured by Weihai Hongyu Nonwoven Fabric Products Co., Ltd.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K120192 · Weihai Hongyu Nonwoven Fabric Products Co., Ltd. · General Hospital
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Oct 2012
Decision
267d
Days
Class 2
Risk

K120192 is an FDA 510(k) clearance for the DISPOSABLE SURGICAL GOWNS. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Weihai Hongyu Nonwoven Fabric Products Co., Ltd. (Weihai, KM). The FDA issued a Cleared decision on October 16, 2012 after a review of 267 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 Weihai Hongyu Nonwoven Fabric Products Co., Ltd. devices

FDA 510(k) Submission Details - K120192

510(k) Number K120192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2012
Decision Date October 16, 2012
Days to Decision 267 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 129d · This submission: 267d
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
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