Cleared Abbreviated

K183132 - Halyard Pink Underguard Nitrile Powder-...

K183132 is the FDA 510(k) clearance for Halyard Pink Underguard Nitrile Powder-... 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 84-day FDA review.

K183132 · O&M Halyard, Inc. · General Hospital
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Feb 2019
Decision
84d
Days
Class 1
Risk

K183132 is an FDA 510(k) clearance for the Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Ch.... Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by O&M Halyard, Inc. (Alpharetta, US). The FDA issued a Cleared decision on February 5, 2019 after a review of 84 days - a notably fast clearance 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 K183132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2018
Decision Date February 05, 2019
Days to Decision 84 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
45d faster than avg
Panel avg: 129d · This submission: 84d
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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