Cleared Traditional

K823234 - RADIATION STERILIZATION OF SURG. GLOVES (FDA 510(k) Clearance)

K823234 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General & Plastic Surgery device
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Apr 1984
Decision
533d
Days
-
Risk

K823234 is an FDA 510(k) clearance for the RADIATION STERILIZATION OF SURG. GLOVES.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Walker, US). The FDA issued a Cleared decision on April 17, 1984 after a review of 533 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 & Plastic Surgery submissions.

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Submission Details

510(k) Number K823234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1982
Decision Date April 17, 1984
Days to Decision 533 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
419d slower than avg
Panel avg: 114d · This submission: 533d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -