# K991757: Non-Absorbable Gauze for External Use, Sterile and Non Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Furlong Industries
- Decided: Aug 12, 1999 after 80 days
- Product code: EFQ (Gauze/Sponge, Internal)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
These devices, both sterile and non sterile, are indicated for external use only and are intended to be used to clean wounds, to scrub or prepare incision sites, to absorb fluids and dress wounds

Source page: https://510kreport.com/device/K991757
Methodology: https://510kreport.com/methodology