Cleared Special

K260312 - Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim

Also marketed or referenced as:
Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid

K260312 is an FDA 510(k) clearance for Nitrile Powder Free Examination Glove, manufactured by Gmp Medicare Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Special 510(k) pathway after a 221-day FDA review.

K260312 · Gmp Medicare Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
221d
Days
Class 1
Risk

K260312 is an FDA 510(k) clearance for the Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemothera.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Gmp Medicare Sdn. Bhd. (Klang, MY). The FDA issued a Cleared decision on September 8, 2026 after a review of 221 days - an extended review 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Gmp Medicare Sdn. Bhd. devices

FDA 510(k) Submission Details - K260312

510(k) Number K260312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2026
Decision Date September 08, 2026
Days to Decision 221 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
92d slower than avg
Panel avg: 129d · This submission: 221d
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 1154
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K260312.
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
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
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