Cleared Special

K262014 - PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves

Also marketed or referenced as:
PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves

K262014 is an FDA 510(k) clearance for PUREZERO* MARIN* Nitrile Powder-Free Ex..., manufactured by O&M Halyard, Inc.. The device is a Class 1 General Hospital device with product code LZA cleared through the Special 510(k) pathway after a 36-day FDA review.

K262014 · O&M Halyard, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
36d
Days
Class 1
Risk

K262014 is an FDA 510(k) clearance for the PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by O&M Halyard, Inc. (Alpharetta, US). The FDA issued a Cleared decision on July 21, 2026 after a review of 36 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K262014

510(k) Number K262014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2026
Decision Date July 21, 2026
Days to Decision 36 days
Submission Type Special
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
93d faster than avg
Panel avg: 129d · This submission: 36d
Pathway characteristics
Modification to existing cleared device.

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 K262014.
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K252117 · Sw Technologies, Inc. · Jun 2026
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K253824 · Kanglongda Vietnam Protection Technology Company Limited · Jun 2026
K262014 · PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves
Download PDF FDA Summary O&M Halyard, Inc.