# K092012: Primagard Delta Fit 80,120, 160  Surgical Face Mask (Small, Medium, Large) Model PG4-7061,-7071,-7081, PG4-7062, 7072-70

- Pathway: 510(k) (Special)
- Applicant: Primed Medical Products, Inc.
- Decided: Sep 25, 2009 after 81 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: 2 generations back to K001951 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081633: Primagard 80, 120, 160 Fluid Resistant Procedure/Surgical Face Masks, Primed Medical Products, Inc. (2008) Summary page 1.

## Indications for use
PRIMAGARD Delta Surgical Masks are surgical apparel as identified in 21 CFR 878.4040 and are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Source page: https://510kreport.com/device/K092012
Methodology: https://510kreport.com/methodology