ARISTA AND ORIENT SURGICAL GLOVES— 510(k) K884633

Name: FDA 510(k) clearance K884633
Creator: U.S. Food and Drug Administration
Published: 1989-04-20

Substantially Equivalent

Durante Intl., Inc.

FDA 510(k) clearance K884633 for ARISTA AND ORIENT SURGICAL GLOVES, Substantially Equivalent on 1989-04-20. Applicant: Durante Intl., Inc.. Device class: 1.

Clearance details

Applicant: Durante Intl., Inc.
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 1988-11-07
Decision date: 1989-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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