# K081633: Primagard 80, 120, 160 Fluid Resistant Procedure/Surgical Face Masks

- Pathway: 510(k) (Special)
- Applicant: Primed Medical Products, Inc.
- Decided: Aug 11, 2008 after 61 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 K001951 (2000). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001951: Primed Pleated Tie-Back, Procedure Mask PM4-305, Primed Pleated Ear-Loop, Procedure Mask PM4-306, Primeline Medical Products, Inc. (2000) Summary page 1.

## Most influential descendants
- K240286: PRIMED Surgical Masks and PRIMED Procedure Masks (2024), 1 descendant of its own
- K252964: PRIMED Surgical and Procedure Masks (2025), 0 descendants of its own
- K092012: Primagard Delta Fit 80,120, 160  Surgical Face Mask (Small, Medium, Large) Model PG4-7061,-7071,-7081, PG4-7062, 7072-70 (2009), 0 descendants of its own

## Indications for use
PRIMAGARDTM Surgical Masks (see complete list of specific model names and numbers on following page) 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/K081633
Methodology: https://510kreport.com/methodology