# K190018: Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Ansell Healthcare Products, LLC
- Decided: May 23, 2019 after 139 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: 2 generations back to K013302 (2001). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111139: Derma Prene Isotouch Green Sterile Powder-Free Polyisoprene Surgical Goves, Tested for U, Ansell Healthcare Products, Inc. (2011) Summary page 5.

## Most influential descendants
- 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

## Indications for use
Gammex Non Latex PI White Surgical Gloves Tested for Use with Chemotherapy Drugs are intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Test Chemotherapy drug & Concentration Average Breakthrough Detection Times(Minutes) Blenoxane, 15 mg/ml >240 Busulfan, 6 mg/ml >240 Carmustine (BCNU), 3.3 mg/ml 10.2 Cisplatin , 1.0 mg/ml >240 Cyclophosphamide (Cytoxan), 20.0 mg/ml >240 Cytarabine , 100 mg/ml >240 Dacarbazine (DTIC), 10.0 mg/ml >240 Daunorubicin , 5 mg/ml >240 Docetaxel, 10.0 mg/ml >240 Doxorubicin Hydrochloride, 2.0 mg/ml >240 Etoposide (Toposar), 20.0 mg/ml >240 Fludarabine , 25 mg/ml >240 Fluorouracil , 50.0 mg/ml >240 Gemcitabine (Gemzar), 38 mg/ml >240 ldarubicin , 1 mg/ml >240 lfosfamide , 50.0 mg/ml >240 Irinotecan , 20.0 mg/ml >240 Mechlorethamine HCI, 1.0 mq/ml >240 Melphalan, 5 mg/ml >240 Methotrexate , 25 mg/ml, >240 Mitomycin C, 0.5 mg/ml >240 Mitoxantrone, 2.0mq/ml >240 Oxaliplatin , 2.0 mq/ml >240 Paclitaxel (Taxol), 6.0 mq/ml >240 Paraplatin , 10 mg/ml >240 Thiotepa , 10.0 mg/ml 11.5 Vincristine Sulfate, 1.0 mg/ml >240 Ellence 2 mg/ml >240 Rituximab 10 mg/ml >240 Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 10.2 minutes and Thiotepa: 11.5 minutes. Warning: Do not use with Carmustine and Thiotepa

Source page: https://510kreport.com/device/K190018
Methodology: https://510kreport.com/methodology