Cleared Traditional

K200847 - Surgical Face Mask

K200847 is the FDA 510(k) clearance for Surgical Face Mask by Mexpo International, Inc.. It is a Class 2 General Hospital device (product code FXX) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K200847 · Mexpo International, Inc. · General Hospital
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Apr 2020
Decision
23d
Days
Class 2
Risk

K200847 is an FDA 510(k) clearance for the Surgical Face Mask. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Mexpo International, Inc. (Union City, US). The FDA issued a Cleared decision on April 23, 2020 after a review of 23 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mexpo International, Inc. devices

Submission Details

510(k) Number K200847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2020
Decision Date April 23, 2020
Days to Decision 23 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 129d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 433
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K200847.
Asept Surgical Face Mask
K201137 · Pfm Medical, Inc. · Aug 2020
Surgical Mask
K201871 · C & S Paper Yunfu Co., Ltd. · Aug 2020
DemeMASK
K201479 · Demetech Corporation · Jul 2020
ClearMask Transparent Surgical Face Mask
K200576 · Clearmask, LLC · Apr 2020
Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip
K192374 · Cardinal Health200, LLC · Dec 2019
3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask
K191355 · 3M Healthcare · Sep 2019