FDA 510(k)

Cardinal Health Level 3 Surgical Mask with Anti-Fog Foam Strip

K-Number: K192374 · 2019-12-02

Decision Date2019-12-02

Product CodeFXX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Cardinal Health Level 3 Surgical Mask with Anti-Fog Foam Strip is a medical device manufactured by Cardinal Health200, LLC. It received FDA 510(k) clearance on 2019-12-02 under approval number K192374. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cardinal Health Level 3 Surgical Mask with Anti-Fog Foam Strip?

Cardinal Health Level 3 Surgical Mask with Anti-Fog Foam Strip is a medical device that received FDA 510(k) clearance on 2019-12-02. It is manufactured by Cardinal Health200, LLC. The 510(k) number is K192374.

When was Cardinal Health Level 3 Surgical Mask with Anti-Fog Foam Strip approved by the FDA?

Cardinal Health Level 3 Surgical Mask with Anti-Fog Foam Strip received FDA 510(k) clearance on 2019-12-02, under approval number K192374.

What company makes Cardinal Health Level 3 Surgical Mask with Anti-Fog Foam Strip?

Cardinal Health Level 3 Surgical Mask with Anti-Fog Foam Strip is manufactured by Cardinal Health200, LLC.

What is the FDA product code for Cardinal Health Level 3 Surgical Mask with Anti-Fog Foam Strip?

The FDA product code for Cardinal Health Level 3 Surgical Mask with Anti-Fog Foam Strip is FXX.

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Other Devices by Cardinal Health200, LLC

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Related Devices (Code: FXX)

K153409Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC K160269Surgical Face Masks (Ear loops and Tie-on)San-M Package Co., Ltd. K152197Skypro, SP01 MaskSkypro Medical Supplies Company K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd. K152561Communicator Surgical Facemask with Clear WindowPrestige Ameritech , Ltd. K171162Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap ShieldPrestige Ameritech

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.