# K042574: Esteem Blue Polyisoprene Surgical Gloves with Coating (Containing Chitosan, Provitamin B, Gluconolactone and Glycerol)

- Pathway: 510(k) (Traditional)
- Applicant: Cardinalhealth
- Decided: Dec 8, 2004 after 77 days
- Product code: KGO (Surgeon'S Gloves)
- Device class: 1
- Regulation: 21 CFR 878.4460
- Recalls of this device: 8 (0 Class I)
- 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.
1 later device descends 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)
- K011721: Esteem Sterile Polyisoprene Surgical Gloves, Allegiance Healthcare Corp. (2001)

## Most influential descendants
- K111868: Sterile Polyisoprene Powder-Free Blue Surgical Gloves with Neu-Thera Emollient Coating (2011), 0 descendants of its own

## Recalls of this device
- Apr 24, 2009 · Not classified · Z-1450-2009: Increase in the number of customer complaints due to cuff tears.
- Apr 24, 2009 · Not classified · Z-1451-2009: Increase in the number of customer complaints due to cuff tears.
- Apr 24, 2009 · Not classified · Z-1449-2009: Increase in the number of customer complaints due to cuff tears.
- Apr 24, 2009 · Not classified · Z-1452-2009: Increase in the number of customer complaints due to cuff tears.
- Apr 24, 2009 · Not classified · Z-1448-2009: Increase in the number of customer complaints due to cuff tears.
- Apr 24, 2009 · Not classified · Z-1447-2009: Increase in the number of customer complaints due to cuff tears.
- Apr 24, 2009 · Not classified · Z-1445-2009: Increase in the number of customer complaints due to cuff tears.
- Apr 24, 2009 · Not classified · Z-1446-2009: Increase in the number of customer complaints due to cuff tears.

## 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. These gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility.

Source page: https://510kreport.com/device/K042574
Methodology: https://510kreport.com/methodology