Cleared Traditional

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

Sep 2019

Decision

217d

Days

Class 2

Risk

About This 510(k) Submission

K190308 is an FDA 510(k) clearance for the 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), a Pediatric/child Facemask (Class II — Special Controls, product code OXZ), submitted by Amd Medicom, Inc. (Montreal, CA). The FDA issued a Cleared decision on September 17, 2019, 217 days after receiving the submission on February 12, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.

Submission Details

510(k) Number	K190308 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 12, 2019
Decision Date	September 17, 2019
Days to Decision	217 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	OXZ — Pediatric/child Facemask
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4040
Definition	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.