# K190308: 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)

- Pathway: 510(k) (Traditional)
- Applicant: Amd Medicom, Inc.
- Decided: Sep 17, 2019 after 217 days
- Product code: OXZ (Pediatric/Child Facemask)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K970835 (1997). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160100: Prestige Ameritech Pediatric/Child’s Face mask, Prestige Ameritech (2016) Summary page 5.

## Indications for use
Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Mask (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Mask, Medicom SafeMask Premier Pediatric Procedure Earloop Face Mask (ASTM Level 1) and Medicom SafeMask Premier Pediatric Procedure Earloop Face Mask are intended to be worn by the patient/child (recommended 4-12 years of age). The face mask is to be placed on nose and mouth as a protective barrier to provide respiratory protection in procedures or situations where there is a risk of microorganism, body fluid and particulate aerosol transfer. It is a single use, non-sterile disposable device that is recommended for use in healthcare settings with appropriate adult supervision.

Source page: https://510kreport.com/device/K190308
Methodology: https://510kreport.com/methodology