Cleared Traditional

GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL) (K240545) - FDA 510(k) Clearance

Class I General Hospital device.

K240545 · Genabio Diagnostics, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
183d
Days
Class 1
Risk

K240545 is an FDA 510(k) clearance for the GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemothe.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Genabio Diagnostics, Inc. (Bedford, US). The FDA issued a Cleared decision on August 28, 2024 after a review of 183 days - an extended review cycle.

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 Genabio Diagnostics, Inc. devices

Submission Details

510(k) Number K240545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 129d · This submission: 183d
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.

Regulatory Peers - LZA Polymer Patient Examination Glove

All 489
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K240545.
NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs)
K242812 · Nb Medical Company Limited · Oct 2024
Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
K241909 · O&M Halyard, Inc. · Sep 2024
Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate (Blue)
K241745 · Ksg Medicare Sdn. Bhd. · Sep 2024
Cardinal Health Nitrile Exam Gloves
K241780 · Cardinal Health200, LLC · Aug 2024
Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential
K241528 · Comfort Rubber Gloves Industries Sdn. Bhd. · Aug 2024
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL)
K241970 · Kanglongda Vietnam Protection Technology Company Limited · Aug 2024