# K221165: Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl and Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl

- Pathway: 510(k) (Abbreviated)
- Applicant: Sri Trang Gloves (Thailand) Public Company Limited
- Decided: Nov 20, 2022 after 212 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 PROPOSE THAI 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) 10 mg/mL, >240 minutes Daunorubicin 5§ mg/mL, >240 minutes Docetaxel |0 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 [darubicin 1 mg/mL, >240 minutes WARNING: Not for use with Carmustine or Thiotepa. Ifosfamide 50 mg/mL, >240 minutes Irinotecan 20 mg/mL, >240 minutes Mechlorethamine | 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 | mg/mL, >240 minutes Fentanyl tested as follows: Fentany] citrate 100 mcg/2mL, >240 minutes

Source page: https://510kreport.com/device/K221165
Methodology: https://510kreport.com/methodology