Cleared Traditional

Medline Glide-On 3G Vinyl Examination Gloves (Tested for use with Chemotherapy Drugs)

K202179 · Medline Industries, Inc. · General Hospital

Oct 2020

Decision

83d

Days

Class 1

Risk

About This 510(k) Submission

K202179 is an FDA 510(k) clearance for the Medline Glide-On 3G Vinyl Examination Gloves (Tested for use with Chemotherapy Drugs), a Vinyl Patient Examination Glove (Class I — General Controls, product code LYZ), submitted by Medline Industries, Inc. (Nortfield, US). The FDA issued a Cleared decision on October 26, 2020, 83 days after receiving the submission on August 4, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number	K202179 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 04, 2020
Decision Date	October 26, 2020
Days to Decision	83 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement

Device Classification

Product Code	LYZ — Vinyl Patient Examination Glove
Device Class	Class I — General Controls
CFR Regulation	21 CFR 880.6250
Definition	A Vinyl Patient Examination Glove Is A Disposable Device Made Of Poly(vinyl Chloride) 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.