Cleared Abbreviated

K160709 - HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves

K160709 is an FDA 510(k) clearance for HALYARD* PURPLE NITRILE – XTRA* Powder-..., manufactured by Halyard Health. The device is a Class 1 General Hospital device with product code LZC cleared through the Abbreviated 510(k) pathway after a 176-day FDA review.

K160709 · Halyard Health · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
176d
Days
Class 1
Risk

K160709 is an FDA 510(k) clearance for the HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves. Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by Halyard Health (Alpharetta, US). The FDA issued a Cleared decision on September 6, 2016 after a review of 176 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 Halyard Health devices

FDA 510(k) Submission Details - K160709

510(k) Number K160709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2016
Decision Date September 06, 2016
Days to Decision 176 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
47d slower than avg
Panel avg: 129d · This submission: 176d
Pathway characteristics
Standards-based clearance path.

LZC Device Classification - Class 1, General Controls

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 63
Devices cleared under the same product code (LZC) and FDA review panel - the closest regulatory comparables to K160709.
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM
K162186 · Brightway Holdings Sdn. Bhd. · Mar 2017
Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
K163017 · Gmp Medicare Sdn. Bhd. · Mar 2017
POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs
K163146 · Hebei Hongsen Plastics Technology Co, Ltd. · Feb 2017
Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs
K151390 · Maxter Glove Manufacturing Sdn Bhd · May 2016
NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs
K152222 · Gmp Medicare Sdn Bhd (F25) · Apr 2016
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K141982 · Wrp Asia Pacific Sdn. Bhd. · Feb 2015