# K142990: Insta-Gard Surgical and Procedure Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health200, LLC
- Decided: Mar 4, 2015 after 139 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: 4 generations back to K874608 (1987). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110455: Kimberly-Clark Low Barrier, Astm 2100 Face Masks, Kimberly-Clark Corp. (2011) Summary page 4.

## Most influential descendants
- K203265: nPro Surgical Mask (2021), 0 descendants of its own

## Indications for use
Cardinal Health Insta-Gard® surgical and procedure mask is intended to be worn by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates. The Cardinal Health Insta-Gard® surgical and procedure masks are single use, disposable devices provided non-sterile. This submission covers 15 catalog numbers of Insta-Gard® surgical and procedure masks models, see Table 1 below. Each model is a three-layer mask of varying composition and has been tested according to ASTM F2100-11 Standard Specification for Performance of Materials Used in Medical Face Masks and meets Level 1 criteria.

Source page: https://510kreport.com/device/K142990
Methodology: https://510kreport.com/methodology