Cleared Abbreviated

K110455 - KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS

K110455 is an FDA 510(k) clearance for KIMBERLY-CLARK LOW BARRIER, manufactured by Kimberly-Clark Corp.. The device is a Class 2 General Hospital device with product code FXX cleared through the Abbreviated 510(k) pathway after a 73-day FDA review.

K110455 · Kimberly-Clark Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
73d
Days
Class 2
Risk

K110455 is an FDA 510(k) clearance for the KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Kimberly-Clark Corp. (Roswell, US). The FDA issued a Cleared decision on April 29, 2011 after a review of 73 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 Kimberly-Clark Corp. devices

FDA 510(k) Submission Details - K110455

510(k) Number K110455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2011
Decision Date April 29, 2011
Days to Decision 73 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 129d · This submission: 73d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

FXX Device Classification - Class 2, Special Controls

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 Consultant

Underwriters Laboratories, Inc.
CASEY CONRY

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FXX Mask, Surgical

All 522
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K110455.
CROSSTEX ISOFLUID PLUS SURGICAL EARLOOP MASK-BLUE, CROSSTEX ISOFLUID PLUS FOGFREE SURGICAL EARLOOP FACE MASK-BLUE, CROSS
K111343 · Crosstex International, Inc. · Oct 2011
SURGICAL MASKS
K111559 · Shanghai Neo-Medical Import & Export Co., Ltd. · Sep 2011
SURGICAL FACE MASK
K110027 · Angeline Group , Ltd. · Aug 2011
TIGER FLAT SURGICAL MASK
K102713 · Tiger Medical Products, Ltd. · Jan 2011
CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE, NO FOG MASK WITH SPLASH VISOR-WHITE
K103303 · Crosstex International, Inc. · Dec 2010
SURGICAL FACE MASK
K093901 · Epard Protective Products, Ltd. · Sep 2010

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.