Cleared Traditional

K103406 - MICROCOOL BREATHABLE HIGH PERFORMANCE S...

K103406 is an FDA 510(k) clearance for MICROCOOL BREATHABLE HIGH PERFORMANCE S..., manufactured by Kimberly-Clark Corp.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K103406 · Kimberly-Clark Corp. · General Hospital
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Dec 2010
Decision
34d
Days
Class 2
Risk

K103406 is an FDA 510(k) clearance for the MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS. 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 December 23, 2010 after a review of 34 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kimberly-Clark Corp. devices

FDA 510(k) Submission Details - K103406

510(k) Number K103406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2010
Decision Date December 23, 2010
Days to Decision 34 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 129d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Underwriters Laboratories, Inc.
NED DEVINE

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 159
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K103406.
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FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.