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Pediatric/Child Facemask

FDA product code OXZ · 9 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.4040
Review panel
HO
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2011-09-23 – 2023-12-21

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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