LATEX EXAMINATION GLOVES, POWDER FREE— 510(k) K970977

Name: FDA 510(k) clearance K970977
Creator: U.S. Food and Drug Administration
Published: 1997-06-27

Substantially Equivalent

Arista Medi Prima

FDA 510(k) clearance K970977 for LATEX EXAMINATION GLOVES, POWDER FREE, Substantially Equivalent on 1997-06-27. Applicant: Arista Medi Prima. Device class: 1.

Clearance details

Applicant: Arista Medi Prima
Product code: Code LYY
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 1997-03-14
Decision date: 1997-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jakarta Barat, ID

Download summary PDF View on FDA.gov ↗

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