Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating— 510(k) K151778

Name: FDA 510(k) clearance K151778
Creator: U.S. Food and Drug Administration
Published: 2016-03-24

Substantially Equivalent

Cardinal Health 200, Inc.

FDA 510(k) clearance K151778 for Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating, Substantially Equivalent on 2016-03-24. Applicant: Cardinal Health 200, Inc.. Device class: 1.

Clearance details

Applicant: Cardinal Health 200, Inc.
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 2015-07-01
Decision date: 2016-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukegan, IL, US

Download summary PDF View on FDA.gov ↗

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