Cleared Abbreviated

MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400 (K091357) - FDA 510(k) Clearance

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

K091357 · Kimberly-Clark Corp. · General Hospital
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Optimized for regulatory review, auditing and printing
Aug 2009
Decision
94d
Days
Class 2
Risk

K091357 is an FDA 510(k) clearance for the MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Kimberly-Clark Corp. (Roswell, US). The FDA issued a Cleared decision on August 10, 2009 after a review of 94 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 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 Kimberly-Clark Corp. devices

Submission Details

510(k) Number K091357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2009
Decision Date August 10, 2009
Days to Decision 94 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
35d faster than avg
Panel avg: 129d · This submission: 94d
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 106
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K091357.
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MEDLINE STERILE DISPOSABLE SURGICAL GOWNS
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PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNS
K043017 · Medline Industries, Inc. · Mar 2005
MEDLINE SURGICAL GOWNS
K043585 · Medline Industries, Inc. · Mar 2005