Cleared Traditional

MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES

K141042 · Mercator Medical (Thailand), Ltd. · General Hospital
Mar 2015
Decision
330d
Days
Class 1
Risk

About This 510(k) Submission

K141042 is an FDA 510(k) clearance for the MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES, a Latex Patient Examination Glove (Class I — General Controls, product code LYY), submitted by Mercator Medical (Thailand), Ltd. (Littleton, US). The FDA issued a Cleared decision on March 19, 2015, 330 days after receiving the submission on April 23, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K141042 FDA.gov
FDA Decision Cleared SESE
Date Received April 23, 2014
Decision Date March 19, 2015
Days to Decision 330 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

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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