NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE WITH CHENITRILE POWDER FREE EXAMINATION (ABLU) TESTED FOR U— 510(k) K120336

Name: FDA 510(k) clearance K120336
Creator: U.S. Food and Drug Administration
Published: 2012-06-25

Substantially Equivalent

Hartalega Sdn Bhd

FDA 510(k) clearance K120336 for NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE WITH CHENITRILE POWDER FREE EXAMINATION (ABLU) TESTED FOR U, Substantially Equivalent on 2012-06-25. Applicant: Hartalega Sdn Bhd. Device class: 1.

Clearance details

Applicant: Hartalega Sdn Bhd
Product code: Code LZC
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2012-02-03
Decision date: 2012-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bestari Jaya, MY

Download summary PDF View on FDA.gov ↗

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