# K202697: United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask

- Pathway: 510(k) (Abbreviated)
- Applicant: United Sewing Automation, Inc.
- Decided: May 13, 2021 after 239 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: 7 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)
- K160269: Surgical Face Masks (Ear loops and Tie-on), San-M Package Co., Ltd. (2016) Summary page 4.
- K191355: 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask, 3M Healthcare (2019) Summary page 8.

## Indications for use
The United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Face Mask and United Sewing High Fluid Resistant Procedure Face Mask are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. These face masks are single-use, disposable devices, provided non-sterile.

Source page: https://510kreport.com/device/K202697
Methodology: https://510kreport.com/methodology