# K240930: Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue; Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Blue

- Pathway: 510(k) (Abbreviated)
- Applicant: Sri Trang Gloves Thailand (Public Company Limited)
- Decided: Jul 2, 2024 after 89 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
THIS DEVICE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER. The tested chemotherapy drugs and permeation times are as follows: Bleomycin Sulfate 15 mg/mL, >240 minutes Busulfan 6 mg/mL, >240 minutes Carboplatin (Paraplatin) 10 mg/mL, >240 minutes Carmustine (BCNU) 3.3 mg/mL, 23.5 minutes Cisplatin 1.0 mg/mL, >240 minutes Cyclophosphamide (Cytoxan) 20 mg/mL, >240 minutes Cytarabine 100 mg/mL, >240 minutes Dacarbazine (DTIC) IO mg/mL, >240 minutes Daunorubicin 5 mg/mL, >240 minutes Docetaxel 10 mg/mL, >240 minutes Doxorubicin Hydrochloride 2 mg/mL, >240 minutes Epirubicin (Ellence) 2 mg/mL, >240 minutes Etoposide (Toposar) 20 mg/mL, >240 minutes Fludarabine 25 mg/mL, >240 minutes Fluorouracil 50 mg/mL, >240 minutes Gemcitabine 38 mg/mL, >240 minutes Idarubicin 1 mg/mL, >240 minutes Bendamustine (5.0 mg / ml), > 240 minutes Oxaliplatin (5.0 mg / ml), > 240 minutes Azacitidine (Vidaza] (25.0 mg / ml) ,> 240 minutes Capecitabine (26.0 mg / ml), > 240 minutes Cladribine (1.0 mg / ml), > 240 minutes Decitabine (5.0 mg / ml) ,> 240 minutes Pemetrexed (25.0 mg / ml), > 240 minutes Raltitrexed (0.5 mg / ml), > 240 minutes Actinomycin D (0.5mg / ml)(Dactinomycin), > 240 minutes Vinorelbine (10.0 mg / ml), > 240 minutes Vinblastine (1.0 mg / ml), > 240 minutes Fentanyl tested as follows; Fentanyl citrate 100 mcg/2mL, >240 minutes WARNING: Not for use with Carmustine or Thiotepa. Ifosfamide 50 mg/mL, >240 minutes Irinotecan 20 mg/mL, >240 minutes Mechlorethamine I mg/mL, >240 minutes Melphalan 5 mg/mL, >240 minutes Methotrexate 25 mg/mL, >240 minutes Mitomycin C 0.5 mg/mL, >240 minutes Mitoxantrone 2 mg/mL, >240 minutes Paclitaxel (Taxol) 6 mg/mL, >240 minutes Rituximab 10 mg/mL, >240 minutes Thiotepa 10 mg/mL, 37.9 minutes Trisenox 1 mg/mL , >240 minutes Vincristine Sulfate I mg/mL, >240 minutes Topotecan (1.0 mg / ml), >240 minutes Carfilzomib (2.0 mg / ml), >240 minutes Cetuximab [Erbitux] (2.0 mg / ml), > 240 minutes Temsirolimus (25.0 mg / ml), > 240 minutes Bortezomib [Velcade] (1.0 mg / ml), > 240 minutes Fulvestrant (50.0mg / ml),> 240 minutes Leuprorelin acetate (5.0 mg / ml), > 240 minutes Ganciclovir [Cytovene] (10.0 mg / ml), > 240 minutes Zidopusin (Retrovir) (10.0 mg / ml), > 240 minutes Zoledronic acid (0.8 mg / ml), > 240 minutes Triclosan (3.0 mg / ml), > 240 minutes Chloroquine (50.0 mg / ml), > 240 minutes Cyclosporine A (100.0 mg / ml) , > 240 minutes Propofol (10 mg/ml) (Diprivan), > 240 minutes MESNA (100 mg/ml), > 240 minutes

Source page: https://510kreport.com/device/K240930
Methodology: https://510kreport.com/methodology