Cleared Traditional

K251319 - Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) (FDA 510(k) Clearance)

Also includes:

Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff

Class I General Hospital device.

K251319 · Hartalega NGC Sdn. Bhd. · General Hospital

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Jul 2025

Decision

92d

Days

Class 1

Risk

K251319 is an FDA 510(k) clearance for the Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherap.... 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 30, 2025 after a review of 92 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 Hartalega NGC Sdn. Bhd. devices

Submission Details

510(k) Number	K251319 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 29, 2025
Decision Date	July 30, 2025
Days to Decision	92 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

36d faster than avg

Panel avg: 128d · This submission: 92d

Pathway characteristics

Predicate-based equivalence.

Device Classification

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.