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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
Regulation Description Surgical apparel.
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
KIMBERLY-CLARK CORP.
  SUBSTANTIALLY EQUIVALENT 2
PRESTIGE AMERITECH
  SUBSTANTIALLY EQUIVALENT 1

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