DISPOSABLE VINYL EXAM GLOVE, POWDERED— 510(k) K113790

Name: FDA 510(k) clearance K113790
Creator: U.S. Food and Drug Administration
Published: 2012-03-06

Substantially Equivalent

Full Synergy Medical Products, Inc.

FDA 510(k) clearance K113790 for DISPOSABLE VINYL EXAM GLOVE, POWDERED, Substantially Equivalent on 2012-03-06. Applicant: Full Synergy Medical Products, Inc.. Device class: 1.

Clearance details

Applicant: Full Synergy Medical Products, Inc.
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2011-12-23
Decision date: 2012-03-06
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Rancho Cuamonga, CA, US

Download summary PDF View on FDA.gov ↗

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