Cleared Traditional

K261749 - Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

K261749 is an FDA 510(k) clearance for Cardinal Health Nitrile Blue Examinatio..., manufactured by Cardinalhealth. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K261749 · Cardinalhealth · General Hospital
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Sep 2026
Decision
97d
Days
Class 1
Risk

K261749 is an FDA 510(k) clearance for the Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemother.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Cardinalhealth (Waukegan, US). The FDA issued a Cleared decision on September 2, 2026 after a review of 97 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K261749

510(k) Number K261749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2026
Decision Date September 02, 2026
Days to Decision 97 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 129d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

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 1153
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K261749.
Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)
K261793 · Maxter Healthcare, Inc. · Sep 2026
Biodegradable Nitrile Powder Free Examination Glove, Green
K262542 · Top Glove Sdn. Bhd. · Sep 2026
Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim
K260312 · Gmp Medicare Sdn. Bhd. · Sep 2026
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
PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves
K262014 · O&M Halyard, Inc. · Jul 2026
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue
K254285 · Hartalega NGC Sdn. Bhd. · Jul 2026