Cleared Traditional

STERILE, POWDER-FREE, LATEX EXAM GLOVES, MODELS 2D7018PF SERIES, 2D7028PF SERIES

K081464 · Cardinalhealth · General Hospital
Aug 2008
Decision
93d
Days
Class 1
Risk

About This 510(k) Submission

K081464 is an FDA 510(k) clearance for the STERILE, POWDER-FREE, LATEX EXAM GLOVES, MODELS 2D7018PF SERIES, 2D7028PF SERIES, a Latex Patient Examination Glove (Class I — General Controls, product code LYY), submitted by Cardinalhealth (Waukegan, US). The FDA issued a Cleared decision on August 28, 2008, 93 days after receiving the submission on May 27, 2008. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K081464 FDA.gov
FDA Decision Cleared SESE
Date Received May 27, 2008
Decision Date August 28, 2008
Days to Decision 93 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LYY — Latex Patient Examination Glove
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6250
Definition A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex 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.

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