# K965043: 3M 1830 Fluid Block Anti-Fog Tie-on Surgical Mask and 3M 1830FS Fluid Block Anti-Fog Tie-on Surgical Mask with Face Shie

- Pathway: 510(k) (Traditional)
- Applicant: Minnesota Mining and Mfg. Co.
- Decided: Mar 10, 1997 after 83 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 K913043 (1991). 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)
- K940707: 3M Surgical Mask with Face Sheild, 3M Company (1994) Summary page 1.
- K913043: Modification Tecnol Fluidshield Surgical Masks, Tecnol New Jersey Wound Care, Inc. (1991) Summary page 1.

## Indications for use
The product is intended for use in infection control practices to minimize contamination caused by exhaled microorganisms. In addition, the device is intended to reduce potential exposure of the wearer to blood and body fluids.

Source page: https://510kreport.com/device/K965043
Methodology: https://510kreport.com/methodology