# K093300: Esteem SMT Polyisoprene Powder-Free Surgical Sterile Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health, Inc.
- Decided: Oct 30, 2009 after 9 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 K011721 (2001). 1 ancestor in all.
8 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011721: Esteem Sterile Polyisoprene Surgical Gloves, Allegiance Healthcare Corp. (2001)

## Most influential descendants
- K110272: Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy Drug (2011), 6 descendants of its own
- K152428: SensiCare PI Surgical Gloves (2016), 2 descendants of its own
- K140477: Biogel PS Surgical Glove Series, Biogel Skinsense Surgical Glove Series (2015), 1 descendant of its own
- K193573: Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro (2020), 0 descendants of its own
- K171898: Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs (2017), 0 descendants of its own

## Indications for use
These powder-free surgeon's gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination in the environments within hospitals and other healthcare facilities.

Source page: https://510kreport.com/device/K093300
Methodology: https://510kreport.com/methodology