Cleared Traditional

K192560 - Surgical Gown

K192560 is an FDA 510(k) clearance for Surgical Gown, manufactured by Shandong Kangli Medical Equipment Technology Co., Ltd.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K192560 · Shandong Kangli Medical Equipment Technology Co., Ltd. · General Hospital
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May 2020
Decision
248d
Days
Class 2
Risk

K192560 is an FDA 510(k) clearance for the Surgical Gown. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Shandong Kangli Medical Equipment Technology Co., Ltd. (Zaozhuang, CN). The FDA issued a Cleared decision on May 22, 2020 after a review of 248 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.

FDA 510(k) Submission Details - K192560

510(k) Number K192560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2019
Decision Date May 22, 2020
Days to Decision 248 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
119d slower than avg
Panel avg: 129d · This submission: 248d
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

Mid-Link Consulting Co, Ltd.
Diana Hong

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 296
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K192560.
Surgical Gown (Sterile), Surgical Gown (Non-sterile)
K202706 · B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. · Dec 2020
Modular Toga
K200977 · Operating Room Innovations, Inc. · Aug 2020
Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown
K200824 · Cardinal Health200, LLC · Jul 2020
50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown
K192290 · Xuchang Zhengde Environstar Medical Products Co., Ltd. · Apr 2020
Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve
K193327 · Cardinal Health200, LLC · Mar 2020
AERO CHROME* Breathable Performance Surgical Gowns
K200522 · O&M Halyard, Inc. · Mar 2020
K192560 · Surgical Gown
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