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FDA 510(k)

ClearMask Transparent Surgical Face Mask

K-Number: K200576 · 2020-04-06

ApplicantClearmask, LLC
Decision Date2020-04-06
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ClearMask Transparent Surgical Face Mask is a medical device manufactured by Clearmask, LLC. It received FDA 510(k) clearance on 2020-04-06 under approval number K200576. 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 ClearMask Transparent Surgical Face Mask?

ClearMask Transparent Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2020-04-06. It is manufactured by Clearmask, LLC. The 510(k) number is K200576.

When was ClearMask Transparent Surgical Face Mask approved by the FDA?

ClearMask Transparent Surgical Face Mask received FDA 510(k) clearance on 2020-04-06, under approval number K200576.

What company makes ClearMask Transparent Surgical Face Mask?

ClearMask Transparent Surgical Face Mask is manufactured by Clearmask, LLC.

What is the FDA product code for ClearMask Transparent Surgical Face Mask?

The FDA product code for ClearMask Transparent Surgical Face Mask is FXX.

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.

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