Cleared Special

K254285 - Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue

Also marketed or referenced as:
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Violet Blue

K254285 is an FDA 510(k) clearance for Nitrile Powder Free Examination Gloves ..., manufactured by Hartalega NGC Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Special 510(k) pathway after a 201-day FDA review.

K254285 · Hartalega NGC Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
201d
Days
Class 1
Risk

K254285 is an FDA 510(k) clearance for the Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Hartalega NGC Sdn. Bhd. (Sepang, MY). The FDA issued a Cleared decision on July 20, 2026 after a review of 201 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 Hartalega NGC Sdn. Bhd. devices

FDA 510(k) Submission Details - K254285

510(k) Number K254285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2025
Decision Date July 20, 2026
Days to Decision 201 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
72d slower than avg
Panel avg: 129d · This submission: 201d
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 K254285.
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
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