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510(k) K103150

KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK by Kimberly-Clark — Product Code OXZ

K103150 is an FDA 510(k) premarket notification submitted by Kimberly-Clark for the device "KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK". The FDA issued a decision of Substantially Equivalent on September 23, 2011. The device falls under product code OXZ (Pediatric/Child Facemask), a Class II device regulated under 21 CFR 878.4040. Kimberly-Clark has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2011
Date Received
October 26, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pediatric/Child Facemask
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

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.

Other clearances by Kimberly-Clark

  • K140963 — KIMGUARD SMART-FOLD STERILIZATION WRAP (November 10, 2014)
  • K141294 — U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS (August 25, 2014)
  • K131879 — KC 300 SURGICAL MASK (December 20, 2013)
  • K131841 — KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE (November 7, 2013)
  • K131254 — KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE (August 20, 2013)
  • K120985 — KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING (December 19, 2012)
  • K112805 — KIMGUARD ONE-STEP STERILIZATION WRAP (June 22, 2012)
  • K113340 — KIMBERLY-CLARK CHILD'S FACEMASK (May 4, 2012)
  • K113423 — KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE (March 9, 2012)
  • K112300 — KIMGUARD SMART-FOLD* STERILIZATION WRAP (January 19, 2012)

Other clearances for product code OXZ

  • K221753 — Kangbeier Child Surgical Mask (December 21, 2023)
  • K213427 — PRIMED Pediatric Facemask (November 22, 2022)
  • K210321 — Dukal Corporation Level 1 Pediatric Face Mask (March 29, 2022)
  • K201514 — Child Face Mask (October 10, 2021)
  • K202831 — The iMask Child's Face Mask (August 26, 2021)
  • K190308 — Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), (September 17, 2019)
  • K160100 — Prestige Ameritech Pediatric/Child’s Face mask (October 7, 2016)
  • K113340 — KIMBERLY-CLARK CHILD'S FACEMASK (May 4, 2012)

FDA data resources