Cleared Traditional

K163191 - ComfortGuard Surgical Gown, i600, Film Reinforced

K163191 is an FDA 510(k) clearance for ComfortGuard 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 105-day FDA review.

K163191 · Gri Medical & Electrical Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
105d
Days
Class 2
Risk

K163191 is an FDA 510(k) clearance for the ComfortGuard Surgical Gown, i600, Film Reinforced. 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 February 27, 2017 after a review of 105 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.

FDA 510(k) Submission Details - K163191

510(k) Number K163191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2016
Decision Date February 27, 2017
Days to Decision 105 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
24d faster than avg
Panel avg: 129d · This submission: 105d
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

Sterilization Consulting Services, LLC
Harry L. Shaffer

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 259
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K163191.
RoyalGuard Surgical Gown, i600, Breathable
K172445 · Gri Medical & Electrical Technology Co., Ltd. · Dec 2017
Cardinal Health Non-Reinforced Surgical Gown
K170762 · Cardinal Health200, LLC · Jun 2017
Aero Chrome* Select Breathable Performance Surgical Gowns
K162930 · Halyard Health, Inc. · Apr 2017
ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500
K162442 · Gri Medical & Electrical Technology Co., Ltd. · Dec 2016
Blockade Surgical Gown
K150598 · Medline Industries, Inc. · Apr 2016
Aero Chrome* Breathable Performance Surgical Gown
K153255 · Halyard Health, Inc. · Apr 2016