KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER-— 510(k) K101596

Name: FDA 510(k) clearance K101596
Creator: U.S. Food and Drug Administration
Published: 2010-07-21

Substantially Equivalent

Kimberly-Clark

FDA 510(k) clearance K101596 for KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER-, Substantially Equivalent on 2010-07-21. Applicant: Kimberly-Clark. Device class: 1.

Clearance details

Applicant: Kimberly-Clark
Product code: Code LZC
Device class: Class 1
Regulation: 21 CFR 880.6250
Advisory panel: General Hospital
Date received: 2010-06-08
Decision date: 2010-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roswell, GA, 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.