Cleared Traditional

K172445 - RoyalGuard Surgical Gown

K172445 is an FDA 510(k) clearance for RoyalGuard Surgical Gown, manufactured by Gri Medical & Electrical 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 116-day FDA review.

K172445 · Gri Medical & Electrical Technology Co., Ltd. · General Hospital
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Dec 2017
Decision
116d
Days
Class 2
Risk

K172445 is an FDA 510(k) clearance for the RoyalGuard Surgical Gown, i600, Breathable. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Gri Medical & Electrical Technology Co., Ltd. (Jiaxing, CN). The FDA issued a Cleared decision on December 8, 2017 after a review of 116 days - within the typical 510(k) review window.

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 Gri Medical & Electrical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K172445

510(k) Number K172445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2017
Decision Date December 08, 2017
Days to Decision 116 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
13d faster than avg
Panel avg: 129d · This submission: 116d
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 168
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K172445.
Disposable Ultra Reinforced Surgical Gown
K173847 · Xiantao Rayxin Medical Products Co., Ltd. · Jan 2019
Surgical gown (AE1001, AE2001, AE3001)
K172987 · Gmax Industries, Inc. · Jul 2018
Medline Prevention CoolZone Gown
K172954 · Medline Industries, Inc. · Jun 2018
Cardinal Health Non-Reinforced Surgical Gown
K170762 · Cardinal Health200, LLC · Jun 2017
Blockade Surgical Gown
K150598 · Medline Industries, Inc. · Apr 2016
TOTAL SHIELD SURGICAL
K142166 · Zimmer, Inc. · Aug 2014