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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pediatric/child facemask
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.
Product CodeOXZ
Regulation Number 878.4040
Device Class 2


Premarket Reviews
ManufacturerDecision
AMD MEDICOM, INC.
  SUBSTANTIALLY EQUIVALENT 1
DUKAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PAC-DENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRIMED MEDICAL PRODUCTS INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG SHENGQUAN NEW MATERIAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
XINXIANG KANGBEIER MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Component Incompatible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Angioedema 1 1

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