Cleared Traditional

K261793 - Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)

K261793 is an FDA 510(k) clearance for Powder-free Nitrile Examination Gloves ..., manufactured by Maxter Healthcare, Inc.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K261793 · Maxter Healthcare, Inc. · General Hospital
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Sep 2026
Decision
103d
Days
Class 1
Risk

K261793 is an FDA 510(k) clearance for the Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Maxter Healthcare, Inc. (Rosharon, US). The FDA issued a Cleared decision on September 9, 2026 after a review of 103 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.

View all Maxter Healthcare, Inc. devices

FDA 510(k) Submission Details - K261793

510(k) Number K261793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2026
Decision Date September 09, 2026
Days to Decision 103 days
Submission Type Traditional
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
26d faster than avg
Panel avg: 129d · This submission: 103d
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 K261793.
Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid
K262208 · Yty Industry (Manjung) Sdn Bhd · Oct 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
Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K261749 · Cardinalhealth · 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