Cleared Abbreviated

K150113 - Fusion Black Powder-Free Nitrile Exam Glove (FDA 510(k) Clearance)

Class I General Hospital device.

K150113 · Halyard Health · General Hospital
Jun 2015
Decision
149d
Days
Class 1
Risk

K150113 is an FDA 510(k) clearance for the Fusion Black Powder-Free Nitrile Exam Glove. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Halyard Health (Roswell, US). The FDA issued a Cleared decision on June 18, 2015 after a review of 149 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.

Submission Details

510(k) Number K150113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2015
Decision Date June 18, 2015
Days to Decision 149 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 169d · This submission: 149d
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 50
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K150113.
Syntex Exam Gloves
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K251716 · Basic Medical Technology, Inc. · Aug 2025