Cleared Abbreviated

K093523 - MICRO-TOUCH NITRILE

K093523 is an FDA 510(k) clearance for MICRO-TOUCH NITRILE, manufactured by Ansell Healthcare Products, LLC. The device is a Class 1 General Hospital device with product code LZA cleared through the Abbreviated 510(k) pathway after a 111-day FDA review.

K093523 · Ansell Healthcare Products, LLC · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
111d
Days
Class 1
Risk

K093523 is an FDA 510(k) clearance for the MICRO-TOUCH NITRILE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Ansell Healthcare Products, LLC (Dothan, US). The FDA issued a Cleared decision on March 4, 2010 after a review of 111 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K093523

510(k) Number K093523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2009
Decision Date March 04, 2010
Days to Decision 111 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 129d · This submission: 111d
Pathway characteristics
Standards-based clearance path.

LZA Device Classification - Class 1, General Controls

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 1181
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K093523.
POWDER-FREE NITRILE GLOVES, BLACK
K100369 · Hl Rubber Industries Sdn Bhd · May 2010
NON STERILE POWDER-FREE, NATURAL OR AQUA LANO-E NITRILE EXAMINATION GLOVES, WITH OR WITHOUT CITRUS/ PEPPERMINT SCENT
K092472 · Ascend Eagle, Inc. · Apr 2010
MULTIPLE PRIVATE LABEL
K100162 · Biogreen Yields Sdn.Bhd · Mar 2010
MEDIGUARD NITRILE EXAMINATION GLOVE- BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K093726 · Medline Industries, Inc. · Feb 2010
MULTIPLE NAME MODEL MULTIPLE
K093759 · Gx Corporation Sdn Bhd (Plant 1) · Feb 2010
SR GLOVE, NU GLOVE, HIGHSTRESS MODEL 801, MODEL 802, MODEL 803
K093696 · Central Medicare Sdn Bhd · Feb 2010
K093523 · MICRO-TOUCH NITRILE
Download PDF FDA Summary Ansell Healthcare Pro…