Cleared Abbreviated

K153708 - Halyard Black-Orange Powder-Free Nitrile Exam Glove

K153708 is an FDA 510(k) clearance for Halyard Black-Orange Powder-Free Nitril..., manufactured by Halyard Health. The device is a Class 1 General Hospital device with 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

FDA 510(k) Submission Details - K153708

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 129d · This submission: 99d
Pathway characteristics
Standards-based clearance path.

LZA Device Classification - Class 1, General Controls

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 1012
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K153708.
HG Pro Nitrile Powder Free Examination Gloves
K152479 · Healthy Glove Co., Ltd. · Apr 2016
Powder Free Blue Nitrile Examination Glove
K153562 · Vietglove Corporation · Apr 2016
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU)
K151997 · Hartalega NGC Sdn. Bhd. · Mar 2016
Powder Free Polychloroprene Examination Glove Green
K153510 · Terang Nusa Sdn Bhd · Mar 2016
Jiayuan Nitrile Powder Free Patient Examination Gloves, Blue Color
K152705 · Jiayuan Medical Products Co., Ltd. · Mar 2016
Minghao Nitrile Powder Free Patient Examination Gloves, Blue Color
K152707 · Minghao Medical Products Co., Ltd. · Mar 2016