Cleared Abbreviated

K153708 - Halyard Black-Orange Powder-Free Nitril...

K153708 is the FDA 510(k) clearance for Halyard Black-Orange Powder-Free Nitril... by Halyard Health. It is a Class 1 General Hospital device (product code LZA) cleared through the Abbreviated 510(k) pathway after a 99-day FDA review.

K153708 · Halyard Health · General Hospital
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Mar 2016
Decision
99d
Days
Class 1
Risk

K153708 is an FDA 510(k) clearance for the Halyard Black-Orange Powder-Free Nitrile Exam Glove. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Halyard Health (Alpharetta, US). The FDA issued a Cleared decision on March 31, 2016 after a review of 99 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 Halyard Health devices

Submission Details

510(k) Number K153708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2015
Decision Date March 31, 2016
Days to Decision 99 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 129d · This submission: 99d
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 584
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K153708.
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K161422 · Wrp Asia Pacific Sdn. Bhd. · Oct 2016
Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr)
K161473 · Medline Industries, Inc. · Oct 2016
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
K160560 · Hartalega Sdn Bhd · Aug 2016
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
K150593 · Hartalega Sdn Bhd · Jun 2015
Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs
K150103 · Hartalega Sdn Bhd · Apr 2015
NITRILE EXAMINATION GLOVES WITH ALOE & VITAMIN E, POWDER- FREE
K142685 · Siam Sempermed Corp., Ltd. · Feb 2015