# K210860: Comfort Guard Mask, level 1, Comfort Guard Mask, level 3

- Pathway: 510(k) (Traditional)
- Applicant: Gri-Alleset, Inc.
- Decided: Apr 7, 2022 after 380 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
Non-sterile, single use device designed to create a physical barrier between the mouth and nose of the wearer and potential contaminants in the immediate environment. They are designed to be worn in the operating room, dental offices, isolation and other medical procedures to protect both the patient and healthcare personnel from transfer of microogransims, bodily fluid and particulate matter. Level I surgical Tie Mask,33-3000, 33-3002, 33-3010, 33-3012,33-3020,33-3022, 33-3023, 33-3025, Level I Procedure Mask,33-2000, 33-2002, 33-2010, 33-2012,33-2020,33-2022, 33-2023, 33-2025, Level III Surgical Tie Mask,33-3040, 33-3050, 33-3052, 33-3060, 33-3062 Level III Procedure Mask, 33-2030, 33-2031, 33-2032, 33-2033

Source page: https://510kreport.com/device/K210860
Methodology: https://510kreport.com/methodology