510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K113340Substantially Equivalent

Kimberly-Clark Child's Facemask

Kimberly-Clark Corporation, Roswell GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113340 is the FDA 510(k) clearance record for KIMBERLY-CLARK CHILD'S FACEMASK, a class II device, cleared for Kimberly-Clark on under FDA product code OXZ (Pediatric/Child Facemask). FDA's definition for product code OXZ reads: "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...". FDA records list 122 510(k) clearances for Kimberly-Clark, from to . As of , FDA records show no recalls naming K113340.

Clearance record

Decision date
Received
(172 days to decision)
Product code
OXZ Pediatric/Child Facemask
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Kimberly-Clark 1400 Holcomb Bridge Rd., Roswell GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OXZ

Trailing 12 months

FDA records hold no clearances under product code OXZ in the trailing twelve months.

FDA records show no clearances under product code OXZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OXZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260