# K200897: Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)

- Pathway: 510(k) (Traditional)
- Applicant: Hartalega Sdn Bhd
- Decided: Jun 1, 2020 after 59 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue) is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminations. It is also tested for use against Chemotherapy Drugs. The gloves were tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for 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) 13.4 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) 15.2 Vincristine Sulfate (1.0 mg/ml) >240 Please note that Carmustine and Thiotepa have extremely low permeation times of 13.4 minutes and 15.2 minutes respectively. The Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminations. It is also tested for use against Chemotherapy Drugs. The gloves were tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for 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) 14.5 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) 23.5 Vincristine Sulfate (1.0 mg/ml) >240 Please note that Carmustine and Thiotepa have extremely low permeation times of 13.4 minutes and 15.2 minutes respectively.

Source page: https://510kreport.com/device/K200897
Methodology: https://510kreport.com/methodology