Cleared Traditional

K180217 - VESTEX Apparel (FDA 510(k) Clearance)

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

K180217 · Vestagen Protective Technologies, Inc. · General Hospital
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May 2018
Decision
113d
Days
Class 2
Risk

K180217 is an FDA 510(k) clearance for the VESTEX Apparel. Classified as Surgical Apparel With Material Claims (product code QBW), Class II - Special Controls.

Submitted by Vestagen Protective Technologies, Inc. (Orlando, US). The FDA issued a Cleared decision on May 18, 2018 after a review of 113 days - within the typical 510(k) review window.

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: 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 Vestagen Protective Technologies, Inc. devices

Submission Details

510(k) Number K180217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2018
Decision Date May 18, 2018
Days to Decision 113 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 128d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QBW Surgical Apparel With Material Claims
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
Definition Surgical Apparel With Material Claims Are Devices That Are Intended To Be Worn By Operating Room Personnel During Surgical Procedures To Protect Both The Surgical Patient And The Operating Room Personnel From Transfer Of Microorganisms, Body Fluids, And Particulate Material. Surgical Apparel With Material Claims Contain Components That Have Been Constructed, Treated, Modified, And/or Coated With Substances That Are Intended Or Known To Create Or Enhance A Functional Element Of The Device. Examples Include Fluid Repellency, Soil Retention, Or Antimicrobial Activity.
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.