Cleared Abbreviated

K081569 - DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR USE WITH CHEMOTHERAPY DRUGS (FDA 510(k) Clearance)

Class I General Hospital device.

K081569 · Dynarex Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
100d
Days
Class 1
Risk

K081569 is an FDA 510(k) clearance for the DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Dynarex Corporation (Orangeburg, US). The FDA issued a Cleared decision on September 12, 2008 after a review of 100 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.

View all Dynarex Corporation devices

Submission Details

510(k) Number K081569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2008
Decision Date September 12, 2008
Days to Decision 100 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 128d · This submission: 100d
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 1167
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K081569.
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K251716 · Basic Medical Technology, Inc. · Aug 2025