Cleared Abbreviated

K093726 - MEDIGUARD NITRILE EXAMINATION GLOVE- BL...

K093726 is the FDA 510(k) clearance for MEDIGUARD NITRILE EXAMINATION GLOVE- BL... by Medline Industries, Inc.. It is a Class 1 General Hospital device (product code LZA) cleared through the Abbreviated 510(k) pathway after a 81-day FDA review.

K093726 · Medline Industries, Inc. · General Hospital
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Feb 2010
Decision
81d
Days
Class 1
Risk

K093726 is an FDA 510(k) clearance for the MEDIGUARD NITRILE EXAMINATION GLOVE- BLUE (TESTED FOR USE WITH CHEMOTHERAPY D.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on February 22, 2010 after a review of 81 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Medline Industries, Inc. devices

Submission Details

510(k) Number K093726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2009
Decision Date February 22, 2010
Days to Decision 81 days
Submission Type Abbreviated
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
48d faster than avg
Panel avg: 129d · This submission: 81d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes 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 - LZA Polymer Patient Examination Glove

All 566
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K093726.
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K102032 · Kimberly-Clark Corp. · Sep 2010
PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE)
K092411 · Shen Wei (Usa), Inc. · Oct 2009
MEDLINE NITRILE EXAM GLOVES W/ALOE -GREEN
K090568 · Medline Industries, Inc. · Oct 2009
NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS
K091652 · Hartalega Sdn Bhd · Sep 2009