Cleared Traditional

VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE

K040916 · Vitalcare Group, Inc. · General Hospital

May 2005

Decision

391d

Days

Class 1

Risk

About This 510(k) Submission

K040916 is an FDA 510(k) clearance for the VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE, a Vinyl Patient Examination Glove (Class I — General Controls, product code LYZ), submitted by Vitalcare Group, Inc. (Miami, US). The FDA issued a Cleared decision on May 4, 2005, 391 days after receiving the submission on April 8, 2004. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number	K040916 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 08, 2004
Decision Date	May 04, 2005
Days to Decision	391 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

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.