Cleared Traditional

MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES (K032666) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K032666 · Medline Industries, Inc. · General Hospital
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Mar 2005
Decision
566d
Days
Class 2
Risk

K032666 is an FDA 510(k) clearance for the MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Waukegan, US). The FDA issued a Cleared decision on March 16, 2005 after a review of 566 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Medline Industries, Inc. devices

Submission Details

510(k) Number K032666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2003
Decision Date March 16, 2005
Days to Decision 566 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
437d slower than avg
Panel avg: 129d · This submission: 566d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KKX Drape, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
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 - KKX Drape, Surgical

All 449
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K032666.
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K200238 · Controlrad, Inc. · Apr 2020
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K052833 · Medline Industries, Inc. · Feb 2006
STERI-DRAPE SURGICAL DRAPES
K031287 · 3M Company · Sep 2003