# K070647: Triflex Select

- Pathway: 510(k) (Special)
- Applicant: Cardinal Health, Inc.
- Decided: Jun 22, 2007 after 106 days
- Product code: KGO (Surgeon'S Gloves)
- Device class: 1
- Regulation: 21 CFR 878.4460
- 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 K992171 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992171: Coated Sterile Latex Powder-Free Surgical Gloves with Protein Content Labeling Claim (50 Micrograms or Less), Allegiance Healthcare Corp. (1999) Summary page 1.

## Indications for use
These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility.

Source page: https://510kreport.com/device/K070647
Methodology: https://510kreport.com/methodology