Cleared Abbreviated

K121152 - SURGICAL GOWN, SMS

K121152 is an FDA 510(k) clearance for SURGICAL GOWN, manufactured by Jiangsu Guangda Medical Material, Co., Ltd.. The device is a Class 2 General Hospital device with product code FYA cleared through the Abbreviated 510(k) pathway after a 240-day FDA review.

K121152 · Jiangsu Guangda Medical Material, Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
240d
Days
Class 2
Risk

K121152 is an FDA 510(k) clearance for the SURGICAL GOWN, SMS. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Jiangsu Guangda Medical Material, Co., Ltd. (Chesterfield, US). The FDA issued a Cleared decision on December 12, 2012 after a review of 240 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K121152

510(k) Number K121152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2012
Decision Date December 12, 2012
Days to Decision 240 days
Submission Type Abbreviated
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
111d slower than avg
Panel avg: 129d · This submission: 240d
Pathway characteristics
Standards-based clearance path.

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 266
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K121152.
TOTALSHIELD SURGICAL HELMET SYSTEM
K132386 · Zimmer, Inc. · Dec 2013
SURGICAL GOWN (EO STERILIZED)
K112796 · Cobes Industries Co., Ltd. · Sep 2013
HM SURGICAL GOWN, NON REINFORCED HM SURGICAL GOWN, FABRIC REINFORCED HM SURGICAL GOWN, POLYERINFORCED
K121998 · Changzhou Holymed Products Co., Ltd. · Dec 2012
DISPOSABLE SURGICAL GOWNS
K120192 · Weihai Hongyu Nonwoven Fabric Products Co., Ltd. · Oct 2012
EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV
K120045 · Exact Medical Manufacturing, Inc. · Jun 2012
EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER
K111535 · Exact Medical Manufacturing, Inc. · Aug 2011
K121152 · SURGICAL GOWN, SMS
Download PDF FDA Summary Jiangsu Guangda Medic…