# K203101: Secure Wear USA Surgical Face Mask

- Pathway: 510(k) (Abbreviated)
- Applicant: Secured Ortho Manufacturing of America, LLC
- Decided: Mar 31, 2021 after 168 days
- Product code: FXX (Mask, Surgical)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Secure Wear USA™ Surgical Face Mask is intended to be worn to protect both the patient and the healthcare professional from transfer of microorganisms, body fluids, and particulate material. The surgical face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, non-sterile, disposable device.

Source page: https://510kreport.com/device/K203101
Methodology: https://510kreport.com/methodology