# K913043: Modification Tecnol Fluidshield Surgical Masks

- Pathway: 510(k) (Traditional)
- Applicant: Tecnol New Jersey Wound Care, Inc.
- Decided: Aug 23, 1991 after 64 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- 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 (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K913043
Methodology: https://510kreport.com/methodology