Cleared Abbreviated

K200576 - ClearMask Transparent Surgical Face Mask

K200576 is the FDA 510(k) clearance for ClearMask Transparent Surgical Face Mask by Clearmask, LLC. It is a Class 2 General Hospital device (product code FXX) cleared through the Abbreviated 510(k) pathway after a 32-day FDA review.

K200576 · Clearmask, LLC · General Hospital
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Apr 2020
Decision
32d
Days
Class 2
Risk

K200576 is an FDA 510(k) clearance for the ClearMask Transparent Surgical Face Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Clearmask, LLC (Baltimore, US). The FDA issued a Cleared decision on April 6, 2020 after a review of 32 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Clearmask, LLC devices

Submission Details

510(k) Number K200576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2020
Decision Date April 06, 2020
Days to Decision 32 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 129d · This submission: 32d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code FXX Mask, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FXX Mask, Surgical

All 436
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K200576.
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3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask
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Surgical Face Mask
K182515 · Wuhan Dymex Healthcare Co., Ltd. · May 2019