Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)— 510(k) K151682

Name: FDA 510(k) clearance K151682
Creator: U.S. Food and Drug Administration
Published: 2015-11-17

Substantially Equivalent

Daxwell, LLC

FDA 510(k) clearance K151682 for Powder Free Vinyl Patient Examination Gloves, Clear (non-colored), Substantially Equivalent on 2015-11-17. Applicant: Daxwell, LLC. Device class: 1.

Clearance details

Applicant: Daxwell, LLC
Product code: Code LYZ
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2015-06-22
Decision date: 2015-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, 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.