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510(k) K113340

KIMBERLY-CLARK CHILD'S FACEMASK by Kimberly-Clark — Product Code OXZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2012
Date Received
November 14, 2011
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.

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  • K131841 — KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE (November 7, 2013)
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  • K120985 — KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING (December 19, 2012)
  • K112805 — KIMGUARD ONE-STEP STERILIZATION WRAP (June 22, 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)
  • K112562 — BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER (December 15, 2011)

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)
  • K103150 — KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK (September 23, 2011)