EUDERMIC PF POWDER-FREE SURGICAL GLOVES— 510(k) K001343

Name: FDA 510(k) clearance K001343
Creator: U.S. Food and Drug Administration
Published: 2000-06-12

Substantially Equivalent

Maxxim Medical, Inc.

FDA 510(k) clearance K001343 for EUDERMIC PF POWDER-FREE SURGICAL GLOVES, Substantially Equivalent on 2000-06-12. Applicant: Maxxim Medical, Inc.. Device class: 1.

Clearance details

Applicant: Maxxim Medical, Inc.
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 2000-04-27
Decision date: 2000-06-12
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Hone Path, SC, US

Download summary PDF View on FDA.gov ↗

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