ULTRA TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)— 510(k) K020838

Substantially Equivalent

Ar Alliance Healthcare Sdn. Bhd.

FDA 510(k) clearance K020838 for ULTRA TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS), Substantially Equivalent on 2002-04-23. Applicant: Ar Alliance Healthcare Sdn. Bhd.. Device class: 1.

Clearance details

Applicant
Ar Alliance Healthcare Sdn. Bhd.
Product code
Code LYY
Device class
Class 1
Regulation
21 CFR 880.6250
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Nibong Tebal, Pulau Pinang, MY
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