Cleared Traditional

Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

K251141 · Mercator Medical (Thailand), Ltd. · General Hospital

Nov 2025

Decision

217d

Days

Class 1

Risk

About This 510(k) Submission

K251141 is an FDA 510(k) clearance for the Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Mercator Medical (Thailand), Ltd. (Songkhla, TH). The FDA issued a Cleared decision on November 17, 2025, 217 days after receiving the submission on April 14, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number	K251141 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 14, 2025
Decision Date	November 17, 2025
Days to Decision	217 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement

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.