Cleared Traditional

Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate

K251716 · Basic Medical Technology, Inc. · General Hospital
Aug 2025
Decision
84d
Days
Class 1
Risk

About This 510(k) Submission

K251716 is an FDA 510(k) clearance for the Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate, a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Basic Medical Technology, Inc. (Ontario, US). The FDA issued a Cleared decision on August 27, 2025, 84 days after receiving the submission on June 4, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K251716 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 2025
Decision Date August 27, 2025
Days to Decision 84 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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