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)
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.

View all O&M Halyard, Inc. devices

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 1007
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K262014.
NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLOR
K260794 · Kossan International Sdn Bhd · Aug 2026
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue
K254285 · Hartalega NGC Sdn. Bhd. · Jul 2026
Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution
K252117 · Sw Technologies, Inc. · Jun 2026
Powder Free Nitrile Examination Gloves Non-Sterile Black
K253824 · Kanglongda Vietnam Protection Technology Company Limited · Jun 2026
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
K260867 · Hartalega NGC Sdn. Bhd. · Jun 2026
Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl
K260703 · S&S Glove Corporation · Jun 2026