# K212046: Impertech Surgical Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Impertech Industries, Ltd.
- Decided: Nov 18, 2021 after 141 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: 10 generations back to K874608 (1987). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202595: Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask, Premier Guard USA, LLC (2021) Summary page 4.

## Indications for use
The Impertech Surgical 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 the potential exposure to blood and body fluid. This is a single use, disposable device, provided non-sterile.

Source page: https://510kreport.com/device/K212046
Methodology: https://510kreport.com/methodology