Cleared Traditional

K880384 - KIMBERLY-CLARK X-TRA TRACTION IMPERVIOUS BOOT (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K880384 · Kimberly-Clark Corp. · General & Plastic Surgery device
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Jun 1988
Decision
147d
Days
Class 1
Risk

K880384 is an FDA 510(k) clearance for the KIMBERLY-CLARK X-TRA TRACTION IMPERVIOUS BOOT. Classified as Shoe And Shoe Cover, Conductive (product code BWP), Class I - General Controls.

Submitted by Kimberly-Clark Corp. (Roswell, US). The FDA issued a Cleared decision on June 23, 1988 after a review of 147 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4040 - the FDA general and plastic surgery 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 & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Kimberly-Clark Corp. devices

Submission Details

510(k) Number K880384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1988
Decision Date June 23, 1988
Days to Decision 147 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 114d · This submission: 147d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BWP Shoe And Shoe Cover, Conductive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.