Cleared Special

DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM

K024102 · Allegiance Healthcare Corp. · General Hospital

Dec 2002

Decision

Days

Class 1

Risk

About This 510(k) Submission

K024102 is an FDA 510(k) clearance for the DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM, a Latex Patient Examination Glove (Class I — General Controls, product code LYY), submitted by Allegiance Healthcare Corp. (Mcgraw Park, US). The FDA issued a Cleared decision on December 18, 2002, 6 days after receiving the submission on December 12, 2002. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number	K024102 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 12, 2002
Decision Date	December 18, 2002
Days to Decision	6 days
Submission Type	Special
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.