# K011721: Esteem Sterile Polyisoprene Surgical Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Allegiance Healthcare Corp.
- Decided: Aug 14, 2001 after 71 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.
14 later devices descend from it; 4 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Duraprene Powder-Free Sterile Synthetic Surgical Gloves: named in the summary without a submission number

## Most influential descendants
- K093300: Esteem SMT Polyisoprene Powder-Free Surgical Sterile Gloves (2009), 8 descendants of its own
- 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
- K092304: Esteem Ortho Polyisoprene Powder-Free Surgical Gloves (2009), 1 descendant of its own

## 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/K011721
Methodology: https://510kreport.com/methodology