Cleared Abbreviated

Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 )

K230569 · Cardinalhealth · General Hospital
Jul 2023
Decision
124d
Days
Class 2
Risk

About This 510(k) Submission

K230569 is an FDA 510(k) clearance for the Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 ), a Mask, Surgical (Class II — Special Controls, product code FXX), submitted by Cardinalhealth (Waukegan, US). The FDA issued a Cleared decision on July 3, 2023, 124 days after receiving the submission on March 1, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number K230569 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 2023
Decision Date July 03, 2023
Days to Decision 124 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FXX — Mask, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4040

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