Cleared Abbreviated

SURGICAL GOWN, SMS (K121152) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K121152 · Jiangsu Guangda Medical Material, Co., Ltd. · General Hospital
Download Printable Device Report (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.

View all Jiangsu Guangda Medical Material, Co., Ltd. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 129d · This submission: 240d
Pathway characteristics
Standards-based clearance path.

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 294
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Henan Yadu Level 4 Surgical Gowns (Reinforced)
K252301 · Yadu Medical (Henan) Co., Ltd. · Feb 2026