Cleared Traditional

GenaCheck? Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL)

K240545 · Genabio Diagnostics, Inc. · General Hospital

Aug 2024

Decision

183d

Days

Class 1

Risk

About This 510(k) Submission

K240545 is an FDA 510(k) clearance for the GenaCheck? Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL), a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Genabio Diagnostics, Inc. (Bedford, US). The FDA issued a Cleared decision on August 28, 2024, 183 days after receiving the submission on February 27, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number	K240545 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 27, 2024
Decision Date	August 28, 2024
Days to Decision	183 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.