Cleared Traditional

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black)

K250861 · Hartalega NGC Sdn. Bhd. · General Hospital
Oct 2025
Decision
216d
Days
Class 1
Risk

About This 510(k) Submission

K250861 is an FDA 510(k) clearance for the Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black), a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Hartalega NGC Sdn. Bhd. (Sepang, MY). The FDA issued a Cleared decision on October 23, 2025, 216 days after receiving the submission on March 21, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K250861 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 2025
Decision Date October 23, 2025
Days to Decision 216 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LZA — Polymer Patient Examination Glove
Device Class Class I — 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.

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