Cleared Traditional

K113340 - KIMBERLY-CLARK CHILD'S FACEMASK (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K113340 · Kimberly-Clark · General Hospital
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Optimized for regulatory review, auditing and printing
May 2012
Decision
172d
Days
Class 2
Risk

K113340 is an FDA 510(k) clearance for the KIMBERLY-CLARK CHILD'S FACEMASK. Classified as Pediatric/child Facemask (product code OXZ), Class II - Special Controls.

Submitted by Kimberly-Clark (Roswell, US). The FDA issued a Cleared decision on May 4, 2012 after a review of 172 days - an extended review 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: 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.

View all Kimberly-Clark devices

Submission Details

510(k) Number K113340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2011
Decision Date May 04, 2012
Days to Decision 172 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 128d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OXZ Pediatric/child Facemask
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
Definition A Pediatric/child Facemask Is Intended To Be Worn By The Patient/child To Provide Protection For The Respiratory Tract. It Is A Single Use, Disposable Device That Is Provided Non-sterile. The Facemask Is Recommended For Use In A Healthcare Setting With Appropriate Adult Supervision.
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 - OXZ Pediatric/child Facemask

All 8
Devices cleared under the same product code (OXZ) and FDA review panel - the closest regulatory comparables to K113340.
Kangbeier Child Surgical Mask
K221753 · Xinxiang Kangbeier Medical Technology Co., Ltd. · Dec 2023
PRIMED Pediatric Facemask
K213427 · Primed Medical Products, Inc. · Nov 2022
Dukal Corporation Level 1 Pediatric Face Mask
K210321 · Dukal Corporation · Mar 2022
Child Face Mask
K201514 · Shandong Shengquan New Material Co., Ltd. · Oct 2021
The iMask Child's Face Mask
K202831 · Pac-Dent, Inc. · Aug 2021