510(k) K160100

Prestige Ameritech Pediatric/Childs Face mask by Prestige Ameritech — Product Code OXZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 7, 2016
Date Received: January 19, 2016
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 Prestige Ameritech

K231741 — ProGear® Surgical Mask with Oxafence®, Model AV82030 (September 5, 2024)
K171162 — Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask (August 15, 2017)
K152561 — Communicator Surgical Facemask with Clear Window (June 3, 2016)
K102092 — PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL (October 6, 2010)
K061716 — PRESTIGE AMERITECH FACE MASK (August 14, 2006)

Other clearances for product code OXZ

K221753 — Kangbeier Child Surgical Mask (December 21, 2023)
K213427 — PRIMED Pediatric Facemask (November 22, 2022)
K210321 — Dukal Corporation Level 1 Pediatric Face Mask (March 29, 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)
K113340 — KIMBERLY-CLARK CHILD'S FACEMASK (May 4, 2012)
K103150 — KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK (September 23, 2011)