inforMED
OXZClass II

Pediatric/child Facemask

General, Plastic Surgery · 21 CFR 878.4040

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.

MDR events1All time
Recalls0All time
Registered firms14Currently listed
510(k) clearances9All time

Recent MDR events

1 adverse event reports on file

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Event type breakdown

Injury1

Most-reported manufacturers

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O&m Halyard, Inc.1

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

14 firms currently registered for this product code

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510(k) clearances

9 clearances for this product code

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