Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove— 510(k) K162852

Name: FDA 510(k) clearance K162852
Creator: U.S. Food and Drug Administration
Published: 2017-02-08

Substantially Equivalent

Lucenxia Prescience AG

FDA 510(k) clearance K162852 for Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove, Substantially Equivalent on 2017-02-08. Applicant: Lucenxia Prescience AG. Device class: 1.

Clearance details

Applicant: Lucenxia Prescience AG
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 2016-10-11
Decision date: 2017-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baar, CH

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.