# K221134: Procedure Mask with Ear Loops and Surgical Mask with Ties

- Pathway: 510(k) (Traditional)
- Applicant: Safesource Direct, LLC
- Decided: May 19, 2022 after 30 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
Longest line of descent: 8 generations back to K874608 (1987). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202899: Procedure Mask, Surgical Mask, Kenpax International Limited (2021) Summary page 4.

## Indications for use
The SafeSource Direct Procedure Mask with Ear Loops is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, bodily fluids, and particulate material. These procedure masks are intended for use in infection control practices to reduce the potential exposure to blood and bodily fluid. The procedure masks are single use, disposable devices, provided non-sterile. The SafeSource Direct Surgical Mask with Ties is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, bodily fluids, and particulate material. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and bodily fluid. The surgical masks are single use, disposable devices, provided non-sterile.

Source page: https://510kreport.com/device/K221134
Methodology: https://510kreport.com/methodology