Cleared Abbreviated

K182096 - Halyard Purple Nitrile Max Powder-Free ...

K182096 is the FDA 510(k) clearance for Halyard Purple Nitrile Max Powder-Free ... by Owens & Minor Halyard, Inc.. It is a Class 1 General Hospital device (product code LZA) cleared through the Abbreviated 510(k) pathway after a 91-day FDA review.

K182096 · Owens & Minor Halyard, Inc. · General Hospital
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Nov 2018
Decision
91d
Days
Class 1
Risk

K182096 is an FDA 510(k) clearance for the Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy .... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Owens & Minor Halyard, Inc. (Alpharetta, US). The FDA issued a Cleared decision on November 2, 2018 after a review of 91 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 Owens & Minor Halyard, Inc. devices

Submission Details

510(k) Number K182096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2018
Decision Date November 02, 2018
Days to Decision 91 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
38d faster than avg
Panel avg: 129d · This submission: 91d
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 612
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K182096.
Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green)
K180645 · Hartalega Sdn Bhd · Nov 2018
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K182528 · Haining Medical Products Co., Ltd. · Nov 2018
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff
K180786 · Hartalega Sdn Bhd · Nov 2018
SBG Blue Nitrile Powder Free Medical Examination Glove
K180467 · Showa Best Glove, Inc. · Oct 2018
SBG Black Nitrile Powder Free Medical Examination Glove
K180468 · Showa Best Glove, Inc. · Oct 2018
Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims
K181066 · Eco Medi Glove Sdn. Bhd. · Sep 2018