Cleared Abbreviated

Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs

K180646 · Halyard Health · General Hospital

Jun 2018

Decision

107d

Days

Class 1

Risk

About This 510(k) Submission

K180646 is an FDA 510(k) clearance for the Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs, a Medical Glove, Specialty (Class I — General Controls, product code LZC), submitted by Halyard Health (Alpharetta, US). The FDA issued a Cleared decision on June 27, 2018, 107 days after receiving the submission on March 12, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number	K180646 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 12, 2018
Decision Date	June 27, 2018
Days to Decision	107 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.