# K230079: Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential

- Pathway: 510(k) (Traditional)
- Applicant: Ansell Healthcare Products, LLC
- Decided: Aug 23, 2023 after 225 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: 3 generations back to K013302 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190018: Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs, Ansell Healthcare Products, LLC (2019) Summary page 5.

## Indications for use
These surgical gloves 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, have low dermatitis potential, and are non-pyrogenic. 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 Breakthrough Detection Time (Minutes) Bleomycin (15 mg/ml) >240 Busulfan (6 mg/ml) >240 Carmustine (BCNU) (3.3 mg/ml) 12.6 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 Idarubicin (1 mg/ml) >240 Ifosfamide (50.0 mg/ml) >240 Irinotecan (20.0 mg/ml) >240 Mechlorethamine HCI (1.0 mg/ml) >240 Melphalan (5 mg/ml) >240 Methotrexate (25 mg/ml) >240 Mitomycin C (0.5 mg/ml) >240 Mitoxantrone (2.0 mg/ml) >240 Oxaliplatin (2.0 mg/ml) >240 Paclitaxel (Taxol) (6.0 mg/ml) >240 Paraplatin (10 mg/ml) >240 Thiotepa (10.0 mg/ml) 26.6 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) 12.6 minutes and Thiotepa: 26.6 minutes. Warning Do not use with Carmustine and Thiotepa

Source page: https://510kreport.com/device/K230079
Methodology: https://510kreport.com/methodology