Cleared Traditional

K910110 - TRIPLE LAYER FLUID-RESISTANT MOLDED FAC...

K910110 is the FDA 510(k) clearance for TRIPLE LAYER FLUID-RESISTANT MOLDED FAC... by 3M Company. It is a Class 2 General Hospital device (product code FXX) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K910110 · 3M Company · General Hospital
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Mar 1991
Decision
69d
Days
Class 2
Risk

K910110 is an FDA 510(k) clearance for the TRIPLE LAYER FLUID-RESISTANT MOLDED FACE MASK. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by 3M Company (Cottae Grove, US). The FDA issued a Cleared decision on March 20, 1991 after a review of 69 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 3M Company devices

Submission Details

510(k) Number K910110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1991
Decision Date March 20, 1991
Days to Decision 69 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 129d · This submission: 69d
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 436
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K910110.
FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK
K911891 · Tecnol New Jersey Wound Care, Inc. · Jul 1991
FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VIS
K911907 · Tecnol New Jersey Wound Care, Inc. · Jul 1991
BARRIER* EXTRA PROTECTION PLUS FACE MASK
K910557 · Johnson & Johnson Medical, Inc. · Apr 1991
ANTI-FOR SURGICAL FACE MASK
K905865 · Anago, Inc. · Mar 1991
SURGICAL FACE MASK
K905749 · Anago, Inc. · Mar 1991
3M BRAND EAR LOOP FACE MASK, 2000F
K910182 · 3M Company · Mar 1991