Cleared Abbreviated

K160709 - HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves (FDA 510(k) Clearance)

Class I General Hospital device.

K160709 · Halyard Health · General Hospital
Sep 2016
Decision
176d
Days
Class 1
Risk

K160709 is an FDA 510(k) clearance for the HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves. 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 September 6, 2016 after a review of 176 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 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 K160709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2016
Decision Date September 06, 2016
Days to Decision 176 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 169d · This submission: 176d
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.