FDA 510(k)

Comfort Guard Mask, level 1, Comfort Guard Mask, level 3

K-Number: K210860 · 2022-04-07

Decision Date2022-04-07

Product CodeFXX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 is a medical device manufactured by Gri-Alleset, Inc.. It received FDA 510(k) clearance on 2022-04-07 under approval number K210860. 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 Comfort Guard Mask, level 1, Comfort Guard Mask, level 3?

Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 is a medical device that received FDA 510(k) clearance on 2022-04-07. It is manufactured by Gri-Alleset, Inc.. The 510(k) number is K210860.

When was Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 approved by the FDA?

Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 received FDA 510(k) clearance on 2022-04-07, under approval number K210860.

What company makes Comfort Guard Mask, level 1, Comfort Guard Mask, level 3?

Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 is manufactured by Gri-Alleset, Inc..

What is the FDA product code for Comfort Guard Mask, level 1, Comfort Guard Mask, level 3?

The FDA product code for Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 is FXX.

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Other Devices by Gri-Alleset, Inc.

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Related Devices (Code: FXX)

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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.