STERILE SURGEONS' GLOVES— 510(k) K891621

Name: FDA 510(k) clearance K891621
Creator: U.S. Food and Drug Administration
Published: 1989-04-20

Substantially Equivalent

Albors-Menconi Latex Corp.

FDA 510(k) clearance K891621 for STERILE SURGEONS' GLOVES, Substantially Equivalent on 1989-04-20. Applicant: Albors-Menconi Latex Corp.. Device class: 1.

Clearance details

Applicant: Albors-Menconi Latex Corp.
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 1989-03-17
Decision date: 1989-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Juan, Puerto Rico, 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.