Cleared Abbreviated

K092327 - MICRO-TOUCH NITRA FREE

K092327 is an FDA 510(k) clearance for MICRO-TOUCH NITRA FREE, 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 48-day FDA review.

K092327 · Ansell Healthcare Products, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
48d
Days
Class 1
Risk

K092327 is an FDA 510(k) clearance for the MICRO-TOUCH NITRA FREE. 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 September 21, 2009 after a review of 48 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 Ansell Healthcare Products, LLC devices

FDA 510(k) Submission Details - K092327

510(k) Number K092327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2009
Decision Date September 21, 2009
Days to Decision 48 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 129d · This submission: 48d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
CASEY CONRY

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LZA Polymer Patient Examination Glove

All 1012
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K092327.
POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED, BLUE
K092072 · Gx Corporation Sdn Bhd · Nov 2009
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
POWDER FREE NITRILE EXAMINATION GLOVES, ORANGE (ORANGE SCENTED), WHITE (VANILLA SCENTED)
K092200 · Gx Corporation Sdn Bhd · Sep 2009
NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS
K091652 · Hartalega Sdn Bhd · Sep 2009
POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)
K091147 · Smart Glove Corp. Sdn Bhd · Jul 2009

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.