Cleared Abbreviated

HALYARD* PURPLE NITRILE ? XTRA* Powder-Free Exam Gloves

K160709 · Halyard Health · General Hospital

Sep 2016

Decision

176d

Days

Class 1

Risk

About This 510(k) Submission

K160709 is an FDA 510(k) clearance for the HALYARD* PURPLE NITRILE ? XTRA* Powder-Free Exam Gloves, a Medical Glove, Specialty (Class I — General Controls, product code LZC), submitted by Halyard Health (Alpharetta, US). The FDA issued a Cleared decision on September 6, 2016, 176 days after receiving the submission on March 14, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number	K160709 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	LZC — Medical Glove, Specialty
Device Class	Class I — 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.