# K013302: Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested for Use with Chemotherapy Drugs Labeling Claim

- Pathway: 510(k) (Traditional)
- Applicant: Allegiance Healthcare Corp.
- Decided: Dec 17, 2001 after 75 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.
22 later devices descend from it; 6 cite it directly.
0 of 23 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 Sterile Powder-Free Surgical Gloves: named in the summary without a submission number

## Most influential descendants
- K102500: Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating (2010), 7 descendants of its own
- K110272: Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy Drug (2011), 6 descendants of its own
- K111139: Derma Prene Isotouch Green Sterile Powder-Free Polyisoprene Surgical Goves, Tested for U (2011), 5 descendants of its own
- K190018: Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs (2019), 3 descendants of its own
- K122557: Motex Powder-Free Nitrile Surgical Gloves (2013), 3 descendants of its own

## Indications for use
These gloves are intended for use 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. They are intended to be worn by operating room personnel to protect a surgical wound from contamination.

Source page: https://510kreport.com/device/K013302
Methodology: https://510kreport.com/methodology