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) Official FDA 510(k) Summary (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.

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 1181

Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K254285.

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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

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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

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K254285

Hartalega NGC Sdn. Bhd.

Sepang · MY

Kuan Mun Leong

Regulatory profile

31 submissions 31 cleared

100% clearance rate · Active in General Hospital

View all devices by Hartalega NGC Sdn. Bhd. →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: July 20, 2026. Record added to 510k Database: August 2026. Enriched with classification and manufacturer data: August 2026.

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