# K183354: Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate

- Pathway: 510(k) (Traditional)
- Applicant: Gx Corporation Sdn Bhd
- Decided: Jun 20, 2019 after 199 days
- Product code: LZA (Polymer Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- 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 Patient examination glove is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with chemotherapy drugs as listed below. Chemotherapy Drug permeation and concentration ( Breakthrough Detection Time) in Minutes. The following chemicals have been tested with these gloves. Chemotherapy Drugs: Breakthrough Detection Time in Minutes 1. Carmustine ( BCNU)3.3 mg/ml(3,300 ppm) 54.8 min 2. Cisplatin 1.0 mg/ml ( I,000ppm) >240 min 3. Cyclophosphamide (Cytoxan) 20mg/ml(20,000ppm) >240 min 4. Dacarbazine (DTIC) I 0.0 mg/ml( l 0,000ppm) >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 ( l0,O00ppm) 46.9 min 14.Vincristine Sulfate 1.0 mg/ml ( l,000ppm) >240 min 15. Amethopterin (Methotrexate) 25 mg/ml, (25,000 ppm) >240 min 16. Bleomycin 15 mg/ml (15,000 ppm) >240 min 17. Busulfan 6 mg/ml (6,000 ppm) >240 min 18. Carboplatin IO mg/ml ( I0,000 ppm) >240 min 19. Cytarabine JOO mg/ml (100.000 ppm) >240 min 20. Daunorubicin 5 mg/ml (5,000 ppm) >240 min 21. Doxetacel 10.0 mg/ml (10,000 ppm) >240 min 22. Ellence 2 mg/ml (2,000 ppm) >240 min 23. Fludarabine 25 mg/ml (25,000 ppm) >240 min 24. Gemcitabine (Gemzar) 38 mg/ml (38,000 ppm) >240 min 25. ldarubicin I mg/ml (1,000 ppm) >240 min 26. lrinotecan 20.0 mg/ml (20,000 ppm) >240 min 27. Mechloretamine HCL 1.0 mg/ml (1,000 ppm) >240 min 28. Melphalan 5 mg/ml (5,000 ppm) >240 min 29. Oxaliplatin 2.0 mg.ml (2,000 ppm) >240 min 30. Rituximab IO mg/ml ( I0,000 ppm) >240 min 31. Trisonex 0.1 mg/ml ( I00 ppm) >240 min 32. Vinorelbin IO mg/ml ( I 0,000 ppm) >240 min plus Other Drugs 1. Fentanyl Citrate Injection I 00 mcg/2ml >240min Please Note that the following Drugs have extremely low permeation times : Carmustine : 54,8 minutes and Thio-Tepa: 46.9 minutes.

Source page: https://510kreport.com/device/K183354
Methodology: https://510kreport.com/methodology