Cleared Traditional

SPUNGUARD HOSPITAL COVERALL (K862804) - FDA 510(k) Clearance

K862804 · Kimberly-Clark Corp. · General & Plastic Surgery device
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Aug 1986
Decision
20d
Days
-
Risk

K862804 is an FDA 510(k) clearance for the SPUNGUARD HOSPITAL COVERALL.

Submitted by Kimberly-Clark Corp. (Roswell, US). The FDA issued a Cleared decision on August 11, 1986 after a review of 20 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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

Submission Details

510(k) Number K862804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1986
Decision Date August 11, 1986
Days to Decision 20 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
95d faster than avg
Panel avg: 115d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -