# K111139: Derma Prene Isotouch Green Sterile Powder-Free Polyisoprene Surgical Goves, Tested for U

- Pathway: 510(k) (Traditional)
- Applicant: Ansell Healthcare Products, Inc.
- Decided: Sep 2, 2011 after 133 days
- Product code: KGO (Surgeon'S Gloves)
- Device class: 1
- Regulation: 21 CFR 878.4460
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K013302 (2001). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013302: Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested for Use with Chemotherapy Drugs Labeling Claim, Allegiance Healthcare Corp. (2001) Summary page 1.

## Most influential descendants
- K190018: Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs (2019), 3 descendants of its own
- K221718: Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural) (2022), 1 descendant of its own
- K230079: Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential (2023), 0 descendants of its own
- K230217: Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs (2023), 0 descendants of its own
- K150238: SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With Aloe Vera (Tested of Use with Chemotherapy Drugs) -Natural Color (2015), 0 descendants of its own

## Recalls of this device
- Aug 3, 2023 · Class II · Z-0096-2024: Some surgical glove sterile pouches were not completely sealed.
- Aug 3, 2023 · Class II · Z-0097-2024: Some surgical glove sterile pouches were not completely sealed.
- Feb 19, 2022 · Class II · Z-0838-2022: Transport company failed to stop at the border for required FDA inspection.

## Indications for use
These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination, and are tested for use with chemotherapy drugs. Chemotherapy Drug Permeation (average breakthrough detection time in minutes) (ASTM D6978-05) *Carmustine 15.5 Cyclophosphamide >240 Doxorubicrn Hydrochloride >240 Etoposide (Toposar) >240 5-Fluorouracil >240 Paclitaxel (Taxol) >240 *ThioTEPA 15.5 Methotrexate >240 Vincristine Sulfate >240 Please note that Carmustine and ThioTEPA have an extremely low permeation time of 15.5 minutes.

Source page: https://510kreport.com/device/K111139
Methodology: https://510kreport.com/methodology