# K903987: Triflex (R) Orth Sterile Surgeon's Gloves, Modified

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Oct 11, 1990 after 49 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K151778: Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating (2016), 1 descendant of its own
- K160875: Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating (2016), 0 descendants of its own

Source page: https://510kreport.com/device/K903987
Methodology: https://510kreport.com/methodology