Cleared Traditional

K033789 - LATEX POWDER-FREE EXAMINATION GLOVES WI...

K033789 is the FDA 510(k) clearance for LATEX POWDER-FREE EXAMINATION GLOVES WI... by Cardinalhealth. It is a Class 1 General Hospital device (product code LZC) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K033789 · Cardinalhealth · General Hospital
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Optimized for regulatory review, auditing and printing
May 2004
Decision
155d
Days
Class 1
Risk

K033789 is an FDA 510(k) clearance for the LATEX POWDER-FREE EXAMINATION GLOVES WITH COATING. Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by Cardinalhealth (Mcgaw Park, US). The FDA issued a Cleared decision on May 7, 2004 after a review of 155 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - 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 Cardinalhealth devices

Submission Details

510(k) Number K033789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2003
Decision Date May 07, 2004
Days to Decision 155 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
26d slower than avg
Panel avg: 129d · This submission: 155d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZC Medical Glove, Specialty
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Disposable Medical Glove (examination Or Surgeon’s) Is A Device That May Or May Not Bear A Trace Amount Of Residual Powder And Is Intended To Be Worn On The Hand Or Finger(s) For Medical Purposes To Prevent Contamination. In Addition, These Gloves May Have Specialty Claims Such As Chemotherapy, Etc.
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 - LZC Medical Glove, Specialty

All 41
Devices cleared under the same product code (LZC) and FDA review panel - the closest regulatory comparables to K033789.
POWDER FREE BLUE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL
K083409 · Wrp Asia Pacific Sdn. Bhd. · Jul 2009
POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIM
K083305 · Wrp Asia Pacific Sdn. Bhd. · Jun 2009
KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM
K081089 · Kimberly-Clark Corp. · Jul 2008
STERILE NITRILE POWDER-FREE EXAMINATION GLOVES
K010211 · Allegiance Healthcare Corp. · Feb 2001
FLUORO-SHIELD RADIATION REDUCTION GLOVES
K920620 · Acufex Microsurgical, Inc. · Jun 1993
FLOUROSHIELD RADIATION REDUCTION GLOVE
K893093 · Acufex Microsurgical, Inc. · Feb 1990