Cleared Abbreviated

K242558 - Halyard Black Nitrile Powder-Free Exam ...

K242558 is the FDA 510(k) clearance for Halyard Black Nitrile Powder-Free Exam ... by O&M Halyard, Inc.. It is a Class 1 General Hospital device (product code LZA) cleared through the Abbreviated 510(k) pathway after a 111-day FDA review.

K242558 · O&M Halyard, Inc. · General Hospital
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Dec 2024
Decision
111d
Days
Class 1
Risk

K242558 is an FDA 510(k) clearance for the Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, .... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by O&M Halyard, Inc. (Mechanicsville, US). The FDA issued a Cleared decision on December 17, 2024 after a review of 111 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all O&M Halyard, Inc. devices

Submission Details

510(k) Number K242558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2024
Decision Date December 17, 2024
Days to Decision 111 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 129d · This submission: 111d
Pathway characteristics
Standards-based clearance path.

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 583
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K242558.
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue)
K243441 · Basic Medical Technology, Inc. · Jan 2025
Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K242936 · Sunray Medical Products, Inc. · Jan 2025
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
K243818 · Hartalega NGC Sdn. Bhd. · Jan 2025
Nitrile Powder Free Examination Gloves Biodegradable (Green)
K240269 · Comfort Rubber Gloves Industries Sdn. Bhd. · Oct 2024
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