Cleared Traditional

K191355 - 3M High Fluid-Resistant Surgical Mask a...

K191355 is the FDA 510(k) clearance for 3M High Fluid-Resistant Surgical Mask a... by 3M Healthcare. It is a Class 2 General Hospital device (product code FXX) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K191355 · 3M Healthcare · General Hospital
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Sep 2019
Decision
113d
Days
Class 2
Risk

K191355 is an FDA 510(k) clearance for the 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure.... Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by 3M Healthcare (St. Paul, US). The FDA issued a Cleared decision on September 11, 2019 after a review of 113 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K191355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2019
Decision Date September 11, 2019
Days to Decision 113 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
16d faster than avg
Panel avg: 129d · This submission: 113d
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 K191355.
Surgical Face Mask
K200847 · Mexpo International, Inc. · Apr 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
Surgical Face Mask
K182515 · Wuhan Dymex Healthcare Co., Ltd. · May 2019
Surgical Face Mask
K182514 · Xiantao Zhibo Non-Woven Products Co., Ltd. · Jan 2019
3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield
K180874 · 3M Healthcare · Jul 2018