STERILE HYPOALLERGENIC SURGEONS' GLOVES— 510(k) K896165

Name: FDA 510(k) clearance K896165
Creator: U.S. Food and Drug Administration
Published: 1989-11-22

Substantially Equivalent

Isratech Marketing Corp.

FDA 510(k) clearance K896165 for STERILE HYPOALLERGENIC SURGEONS' GLOVES, Substantially Equivalent on 1989-11-22. Applicant: Isratech Marketing Corp.. Device class: 1.

Clearance details

Applicant: Isratech Marketing Corp.
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 1989-10-25
Decision date: 1989-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, 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.