FDA 510(k) Applications for Medical Device Product Code: OXZ ()

FDA 510(k) Applications for Medical Device Product Code "OXZ"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K190308	AMD Medicom, Inc.	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 Pedia	09/17/2019
K210321	Dukal Corporation	Dukal Corporation Level 1 Pediatric Face Mask	03/29/2022
K113340	KIMBERLY-CLARK	KIMBERLY-CLARK CHILD'S FACEMASK	05/04/2012
K103150	KIMBERLY-CLARK	KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK	09/23/2011
K202831	Pac-Dent, Inc.	The iMask Child's Face Mask	08/26/2021
K160100	Prestige Ameritech	Prestige Ameritech Pediatric/ChildÆs Face mask	10/07/2016
K213427	PRIMED Medical Products Inc.	PRIMED Pediatric Facemask	11/22/2022
K201514	Shandong Shengquan New Material Co., Ltd.	Child Face Mask	10/10/2021