# K200915: Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Gx Corporation Sdn Bhd
- Decided: Jul 9, 2021 after 459 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 White Sterilized Polyisoprene Surgical Gloves- Tested for Use with Chemotherapy Drugs is a disposable device intended for invasive surgery procedures that is to be worn on both the hands by operating room personnel to protect a surgical wound from contamination . These gloves were tested for use with Chemotherapy Drug as per ASTM D 6978 - Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug. List of tested Chemotherapy Drugs are as follows: Chemotherapy Drug Permeation and Concentration Average Breaktrough Detection Time (in Minutes) 1. Carmustine ( BCNU)3.3 mg/ml(3,300 ppm) 12.6 min 2. Cisplatin 1.0 mg/ml (1,000ppm) >240 min 3. Cyclophosphamide (Cytoxan) 20mg/ml(20,000ppm) >240 min 4. Dacarbazine (DTIC)10.0 mg/ml(10,000ppm) >240 min 5. Doxorubicin Hydrochloride 2.0 mg/ml (2,000ppm) >240 min 6. Etoposide (Toposar) 20.0 mg/ml (20,000ppm) >240 min 7. Fluorouracil 50.0 mg/ml (50,000ppm) >240 min 8. Ifosfamide 50.0 mg/ml (50,000ppm) >240 min 9. Methotrexate 25 mg/ml (25,000ppm) >240 min 10. Mitomycin C 0.5 mg/ml (500ppm) >240 min 11. Mitoxantrone 2.0 mg/ml (2,000ppm) >240 min 12.Paclitaxel (Taxol) 6.0 mg/ml (6,000ppm) >240 min 13. Thio-Tepa 10.0 mg/ml (10,000ppm) 12.0 min 14. Vincristine Sulfate 1.0 mg/ml (1,000ppm) >240 min Please Note that Carmustine and Thio-Tepa have low permeation time of less than 240 minutes.

Source page: https://510kreport.com/device/K200915
Methodology: https://510kreport.com/methodology