# K211773: Single-use Surgical Mask

- Pathway: 510(k) (Traditional)
- Applicant: Taiwan Seafood and Fish Corporation
- Decided: Dec 2, 2021 after 177 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: 1 generation back to K202824 (2021). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202824: BRS Procedure Face Mask, Blackbriar Regulatory Services, LLC (2021) Summary page 4.

## Indications for use
The Single Use Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single use device provided non-sterile.

Source page: https://510kreport.com/device/K211773
Methodology: https://510kreport.com/methodology