# K230578: Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl

- Pathway: 510(k) (Traditional)
- Applicant: Wrp Asia Pacific Sdn. Bhd.
- Decided: Aug 31, 2023 after 183 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 K032942 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222058: Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant, Wrp Asia Pacific Sdn. Bhd. (2022) Summary page 5.

## Indications for use
A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn on the hands of healthcare personnel as a barrier for protection against cross-contamination between the healthcare personnel and patient. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Chemotherapy Drug Permeation The following chemicals have been tested with these gloves. Chemotherapy Drug (Concentration) Minimum Breakthrough Detection Time (Minutes) *Carmustine (BCNU) (3.3 mg/ml) 67.6 Cisplatin (1.0 mg/ml) > 240 Cyclophosphamide (Cytoxan) (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 Ifosfamide (50.0 mg/ml) > 240 Methotrexate (25.0 mg/ml) > 240 Mitomycin C (0.5 mg/ml) > 240 Mitoxantrone (2.0 mg/ml) > 240 Paclitaxel (6.0 mg/ml) > 240 *Thiotepa (10.0 mg/ml) 77.7 Vincristine Sulfate (1.0 mg/ml) > 240 *WARNING: Please note the following drugs have extremely low permeation times: Carmustine (BCNU): 67.6 minutes and Thiotepa: 77.7. Do not use with Carmustine and Thiotepa. Fentanyl Concentration Breakthrough Detection Time in Minutes Fentanyl Citrate Injection 100mcg/2mL No breakthrough up to 240 minutes

Source page: https://510kreport.com/device/K230578
Methodology: https://510kreport.com/methodology