ULTREX POWDER-FREE SURGICAL GLOVES/ULTREX POWDER-FREE SURGICAL GLOVES WITH LOW PROTEIN CLAIM— 510(k) K964980

Name: FDA 510(k) clearance K964980
Creator: U.S. Food and Drug Administration
Published: 1997-03-06

Substantially Equivalent

Maxxim Medical

FDA 510(k) clearance K964980 for ULTREX POWDER-FREE SURGICAL GLOVES/ULTREX POWDER-FREE SURGICAL GLOVES WITH LOW PROTEIN CLAIM, Substantially Equivalent on 1997-03-06. Applicant: Maxxim Medical. Device class: 1.

Clearance details

Applicant: Maxxim Medical
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 1996-12-13
Decision date: 1997-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sugar Land, TX, US

Download summary PDF View on FDA.gov ↗

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