Cleared Abbreviated

K150113 - Fusion Black Powder-Free Nitrile Exam Glove

K150113 is an FDA 510(k) clearance for Fusion Black Powder-Free Nitrile Exam Glove, manufactured by Halyard Health. The device is a Class 1 General Hospital device with product code LZA cleared through the Abbreviated 510(k) pathway after a 149-day FDA review.

K150113 · Halyard Health · General Hospital
Download Printable Device Report (PDF)
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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.

View all Halyard Health devices

FDA 510(k) Submission Details - K150113

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 129d · This submission: 149d
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 1012
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K150113.
Powder Free Nitrile Examination Glove
K151208 · Vrg Khai Hoan Joint Stock Company · Sep 2015
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (white, blue, orange)
K151343 · Hartalega NGC Sdn. Bhd. · Aug 2015
NON-STERILE, POWER FREE NITRILE EXAMINATION GLOVES-ORANGE, GREEN, BLUE AND VIOLET COLOR
K143289 · Yty Industry (Manjung) Sdn Bhd · Aug 2015
POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue)
K150340 · Hebei Hongsen Plastics Technology Co, Ltd. · Jun 2015
Midas Touch-Nitrile Examination Gloves- Powder free, Orange, XS, Model SNAEFT-240OR-XS
K150414 · Industrial Clothings (Pvt), Ltd. · Jun 2015
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
K150593 · Hartalega Sdn Bhd · Jun 2015