FDA 510(k) Applications Submitted by Caroline Miceli

FDA 510(k) Number Submission Date Device Name Applicant
K160339 02/08/2016 Cardinal Health Isolation Gown Cardinal Health 200, LLC
K230569 03/01/2023 Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 ) Cardinal Health
K170762 03/13/2017 Cardinal Health Non-Reinforced Surgical Gown Cardinal Health 200, LLC
K200824 03/30/2020 Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown Cardinal Health 200, LLC
K151778 07/01/2015 Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating CARDINAL HEALTH 200, INC.
K182830 10/05/2018 Cardinal HealthTM Poly-Coated Open-Back Protective Gown Cardinal Health 200, LLC
K193327 12/02/2019 Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve Cardinal Health 200, LLC


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