Cleared Traditional

K162442 - ComfortGuard Plus Surgical Gown

K162442 is an FDA 510(k) clearance for ComfortGuard Plus 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 103-day FDA review.

K162442 · Gri Medical & Electrical Technology Co., Ltd. · General Hospital
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Dec 2016
Decision
103d
Days
Class 2
Risk

K162442 is an FDA 510(k) clearance for the ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500. 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 12, 2016 after a review of 103 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 - K162442

510(k) Number K162442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2016
Decision Date December 12, 2016
Days to Decision 103 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
26d faster than avg
Panel avg: 129d · This submission: 103d
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 K162442.
Surgical gown (AE1001, AE2001, AE3001)
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Medline Prevention CoolZone Gown
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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
STRYKER STERI-SHIELD FLYTE HYBRID TOGAS
K141095 · Stryker Corporation · Aug 2014