# K203030: Powder Free Nitrile Surgical Glove, Sterile, Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Wrp Asia Pacific Sdn. Bhd.
- Decided: Jun 11, 2021 after 252 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
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 Concentration Average Breakthrough Detection Time (Minutes) *Carmustine (BCNU) (3.3 mg/ml) 273 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) 26.9 Vincristine Sulfate (1.0 mg/ml) > 240 *WARNING: Do not use Carmustine and ThioTepa.

Source page: https://510kreport.com/device/K203030
Methodology: https://510kreport.com/methodology