Cleared Traditional

K102652 - NON REINFORCED SURGICAL GOWNS

K102652 is the FDA 510(k) clearance for NON REINFORCED SURGICAL GOWNS by Gri Medical & Electronic Technology Co., Ltd.. It is a Class 2 General Hospital device (product code FYA) cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K102652 · Gri Medical & Electronic Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
142d
Days
Class 2
Risk

K102652 is an FDA 510(k) clearance for the NON REINFORCED SURGICAL GOWNS, FILM REINFORCED SURGICAL GOWNS, FABRIC REINFOR.... Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Gri Medical & Electronic Technology Co., Ltd. (Swanee, US). The FDA issued a Cleared decision on February 3, 2011 after a review of 142 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 & Electronic Technology Co., Ltd. devices

Submission Details

510(k) Number K102652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2010
Decision Date February 03, 2011
Days to Decision 142 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 slower than avg
Panel avg: 129d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 148
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K102652.
STRYKER STERI-SHIELD FLYTE HYBRID TOGAS
K141095 · Stryker Corporation · Aug 2014
T4/T5 HYTREL TOGAS
K121664 · Stryker Corporation · Mar 2014
TOTALSHIELD SURGICAL HELMET SYSTEM
K132386 · Zimmer, Inc. · Dec 2013
MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS
K103406 · Kimberly-Clark Corp. · Dec 2010
KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100
K093115 · Kimberly-Clark Corp. · Mar 2010
MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400
K091357 · Kimberly-Clark Corp. · Aug 2009