# K221718: Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)

- Pathway: 510(k) (Traditional)
- Applicant: Hartalega NGC Sdn. Bhd.
- Decided: Sep 24, 2022 after 103 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.
1 later device descends from it; 1 cites it directly.
0 of 5 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.

## Most influential descendants
- K230217: Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs (2023), 0 descendants of its own

## Indications for use
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs is intended to be worn by operating room personnel to protect surgical wound from contamination. It is also tested for use against Chemotherapy Drugs. The gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice fo Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time in Minutes Carmustine (3.3 mg/ml) 12.3 Cisplatin (1.0 mg/ml) >240 Cyclophosphamide (20.0 mg/ml) >240 Dacarbazine (10.0 mg/ml) >240 Doxorubicin Hydrochloride (2.0 mg/ml) >240 Etoposide (20.0 mg/ml) >240 Fluorouracil (50.0 mg/ml) >240 Methotrexate (25.0 mg/ml) >240 Mitomycin C (0.5 mg/ml) >240 Paclitaxel (6.0 mg/ml) >240 Thiotepa (10.0 mg/ml) 17.4 Vincristine Sulfate (1.0 mg/ml) >240 Please note that Carmustine and Thiotepa have extremely low permeation times of 12.3 minutes and 17.4 minutes respectively. Warning: Do not use with Carmustine and Thiotepa

Source page: https://510kreport.com/device/K221718
Methodology: https://510kreport.com/methodology