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510(k) K210321

Dukal Corporation Level 1 Pediatric Face Mask by Dukal Corporation — Product Code OXZ

K210321 is an FDA 510(k) premarket notification submitted by Dukal Corporation for the device "Dukal Corporation Level 1 Pediatric Face Mask". The FDA issued a decision of Substantially Equivalent on March 29, 2022. The device falls under product code OXZ (Pediatric/Child Facemask), a Class II device regulated under 21 CFR 878.4040. Dukal Corporation has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2022
Date Received
February 4, 2021
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 Dukal Corporation

  • K212464 — Dukal Corporation AAMI Level 4 Open-Back Protective Gown (March 30, 2022)
  • K203237 — Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgic (March 18, 2022)
  • K201732 — Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation L (February 16, 2021)
  • K201421 — Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level (February 5, 2021)
  • K113689 — DUKAL LUBRICATING JELLY (May 4, 2012)
  • K070692 — DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK (May 30, 2007)

Other clearances for product code OXZ

  • K221753 — Kangbeier Child Surgical Mask (December 21, 2023)
  • K213427 — PRIMED Pediatric Facemask (November 22, 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)
  • K103150 — KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK (September 23, 2011)

FDA data resources