POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES— 510(k) K120963

Name: FDA 510(k) clearance K120963
Creator: U.S. Food and Drug Administration
Published: 2012-06-29

Substantially Equivalent

Medtexx Manufacturing Sdn. Bhd.

FDA 510(k) clearance K120963 for POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES, Substantially Equivalent on 2012-06-29. Applicant: Medtexx Manufacturing Sdn. Bhd.. Device class: 1.

Clearance details

Applicant: Medtexx Manufacturing Sdn. Bhd.
Product code: Code LYY
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2012-03-30
Decision date: 2012-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kamunting, MY

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.