Cleared Abbreviated

K180646 - Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs (FDA 510(k) Clearance)

Class I General Hospital device.

K180646 · Halyard Health · General Hospital
Jun 2018
Decision
107d
Days
Class 1
Risk

K180646 is an FDA 510(k) clearance for the Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemother.... Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by Halyard Health (Alpharetta, US). The FDA issued a Cleared decision on June 27, 2018 after a review of 107 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.

Submission Details

510(k) Number K180646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2018
Decision Date June 27, 2018
Days to Decision 107 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 169d · This submission: 107d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code LZC Medical Glove, Specialty
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Disposable Medical Glove (examination Or Surgeon’s) Is A Device That May Or May Not Bear A Trace Amount Of Residual Powder And Is Intended To Be Worn On The Hand Or Finger(s) For Medical Purposes To Prevent Contamination. In Addition, These Gloves May Have Specialty Claims Such As Chemotherapy, Etc.
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.