POWDER FREE NITRILE EXAMINATION GLOVES - POLYMER COATED— 510(k) K974443

Name: FDA 510(k) clearance K974443
Creator: U.S. Food and Drug Administration
Published: 1998-01-05

Substantially Equivalent

P.T. Latexindo Tobaperkasa

FDA 510(k) clearance K974443 for POWDER FREE NITRILE EXAMINATION GLOVES - POLYMER COATED, Substantially Equivalent on 1998-01-05. Applicant: P.T. Latexindo Tobaperkasa. Device class: 1.

Clearance details

Applicant: P.T. Latexindo Tobaperkasa
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 1997-11-25
Decision date: 1998-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medan, ID

Download summary PDF View on FDA.gov ↗

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