Cleared Traditional

K822641 - GORE-TEX BARRIER SURG. DRAPES & GOWNS (FDA 510(k) Clearance)

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

K822641 · W.L. Gore & Associates, Inc. · General Hospital
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Jan 1983
Decision
128d
Days
Class 2
Risk

K822641 is an FDA 510(k) clearance for the GORE-TEX BARRIER SURG. DRAPES & GOWNS. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 7, 1983 after a review of 128 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all W.L. Gore & Associates, Inc. devices

Submission Details

510(k) Number K822641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1982
Decision Date January 07, 1983
Days to Decision 128 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 128d · This submission: 128d
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.