Cleared Traditional

INTEGRON SURGICAL GLOVES (K924071) - FDA 510(k) Clearance

Class I General Hospital device.

K924071 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General Hospital
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Nov 1993
Decision
463d
Days
Class 1
Risk

K924071 is an FDA 510(k) clearance for the INTEGRON SURGICAL GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on November 18, 1993 after a review of 463 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4460 - 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K924071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1992
Decision Date November 18, 1993
Days to Decision 463 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
334d slower than avg
Panel avg: 129d · This submission: 463d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGO Surgeon's Gloves
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4460
Definition A Surgeon's Glove Is A Disposable Device Made Of Natural Rubber Latex Or Synthetic Polymers That May Or May Not Bear Powder To Facilitate Donning, And It Is Intended To Be Worn On The Hands, Usually In Surgical Settings, To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KGO Surgeon's Gloves

All 96
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K924071.
DEXTREN(TM) POWDER FREE HYPOALLERGENIC GLOVES
K935869 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1994
DEXTREN POWDER FREE HYPOALLERG GLOVES W/O COLORANTS
K935870 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1994
B-D(R) CHALLENGE POWDER FREE SYNTHETIC SURG GLOVES
K933062 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1994
EUDERMIC POWDER-FREE SURGICAL GLOVES
K915807 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1992
DEXTRON SURGICAL GLOVES
K921804 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1992
RESIST(TM) ORTHOPAEDIC SURGICAL GLOVE
K913893 · Depuy, Inc. · Oct 1992