Cleared Abbreviated

K191230 - Halyard Sterling* Nitrile Powder-Free E...

K191230 is the FDA 510(k) clearance for Halyard Sterling* Nitrile Powder-Free E... by O&M Halyard, Inc.. It is a Class 1 General Hospital device (product code LZC) cleared through the Abbreviated 510(k) pathway after a 184-day FDA review.

K191230 · O&M Halyard, Inc. · General Hospital
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Nov 2019
Decision
184d
Days
Class 1
Risk

K191230 is an FDA 510(k) clearance for the Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitri.... Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by O&M Halyard, Inc. (Mechanicsville, US). The FDA issued a Cleared decision on November 8, 2019 after a review of 184 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.

View all O&M Halyard, Inc. devices

Submission Details

510(k) Number K191230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2019
Decision Date November 08, 2019
Days to Decision 184 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
55d slower than avg
Panel avg: 129d · This submission: 184d
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.

Regulatory Peers - LZC Medical Glove, Specialty

All 40
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