SURGEONS' GLOVES W/HYPOALLERGENICITY CLAIMS— 510(k) K900985

Name: FDA 510(k) clearance K900985
Creator: U.S. Food and Drug Administration
Published: 1990-03-20

Substantially Equivalent

Productes Del Latex, S.A.

FDA 510(k) clearance K900985 for SURGEONS' GLOVES W/HYPOALLERGENICITY CLAIMS, Substantially Equivalent on 1990-03-20. Applicant: Productes Del Latex, S.A.. Device class: 1.

Clearance details

Applicant: Productes Del Latex, S.A.
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 1990-03-01
Decision date: 1990-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, 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.