# K200576: ClearMask Transparent Surgical Face Mask

- Pathway: 510(k) (Abbreviated)
- Applicant: Clearmask, LLC
- Decided: Apr 6, 2020 after 32 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 ClearMask Transparent Surgical Face Mask is intended for use in healthcare settings, such as in operating rooms, or in other medical procedures such as dental, isolation and veterinary procedures during which a face mask is necessary to protect both patient and healthcare personnel from transfer of body fluids, microorganisms, and particulate material. The device allows for full view of the face and facial expressions, particularly the nose and mouth areas. The device is indicated for over-the-counter use. The device is disposable and is indicated for single use. The device is not provided sterile.

Source page: https://510kreport.com/device/K200576
Methodology: https://510kreport.com/methodology