# K202595: Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Premier Guard USA, LLC
- Decided: Jan 21, 2021 after 135 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: 9 generations back to K874608 (1987). 11 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182515: Surgical Face Mask, Wuhan Dymex Healthcare Co., Ltd. (2019) Summary page 4.

## Most influential descendants
- K231618: 3 Layer Surgical Mask (134252531) (2023), 0 descendants of its own
- K212046: Impertech Surgical Face Mask (2021), 0 descendants of its own
- K211861: TAIJI Professional Series Level 3 Surgical Face Mask (2021), 0 descendants of its own

## Indications for use
The Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Masks 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 fluids. This is a single use, disposable device, provided non-sterile.

Source page: https://510kreport.com/device/K202595
Methodology: https://510kreport.com/methodology