OXZ · Class II · 21 CFR 878.4040

FDA Product Code OXZ: Pediatric/child Facemask

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.

Leading manufacturers include Kimberly-Clark, Prestige Ameritech and Amd Medicom, Inc..

9
Total
9
Cleared
353d
Avg days
2011
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Pediatric/child Facemask Devices (Product Code OXZ)

9 devices
1–9 of 9
Cleared Dec 21, 2023
Kangbeier Child Surgical Mask
K221753
Xinxiang Kangbeier Medical Technology Co., Ltd.
General Hospital · 553d
Cleared Nov 22, 2022
PRIMED Pediatric Facemask
K213427
Primed Medical Products, Inc.
General Hospital · 397d
Cleared Mar 29, 2022
Dukal Corporation Level 1 Pediatric Face Mask
K210321
Dukal Corporation
General Hospital · 418d
Cleared Oct 10, 2021
Child Face Mask
K201514
Shandong Shengquan New Material Co., Ltd.
General Hospital · 489d
Cleared Aug 26, 2021
The iMask Child's Face Mask
K202831
Pac-Dent, Inc.
General Hospital · 335d
Cleared Sep 17, 2019
Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1)
K190308
Amd Medicom, Inc.
General Hospital · 217d
Cleared Oct 07, 2016
Prestige Ameritech Pediatric/Child’s Face mask
K160100
Prestige Ameritech
General Hospital · 262d
Cleared May 04, 2012
KIMBERLY-CLARK CHILD'S FACEMASK
K113340
Kimberly-Clark
General Hospital · 172d
Cleared Sep 23, 2011
KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK
K103150
Kimberly-Clark
General Hospital · 332d

About Product Code OXZ - Regulatory Context

510(k) Submission Activity

9 total 510(k) submissions under product code OXZ since 2011, with 9 receiving FDA clearance (average review time: 353 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.