# K200539: Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl

- Pathway: 510(k) (Abbreviated)
- Applicant: Sri Trang Gloves (Thailand) Public Company Limited
- Decided: Apr 9, 2020 after 37 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 purposes 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: Carmustine (BCNU) 3.3 mg/mL, 11.6 minutes Cisplatin 1.0 mg/mL, >240 minutes Cyclophosphamide (Cytoxan) 20 mg/mL, >240 minutes Dacarbazine (DTIC) 10.0 mg/mL, >240 minutes Doxorubicin 2.0 mg/mL, >240 minutes Etoposide (Toposar) 20.0 mg/mL, >240 minutes Fluorouracil 50.0 mg/mL, >240 minutes Methotrexate 25 mg/mL, >240 minutes Paclitaxel (Taxol) 6.0 mg/mL, >240 minutes Thiotepa 10 mg/mL, 36.2 minutes Vincristine Sulfate 1.0 mg/mL, >240 minutes WARNING: Not for use with Carmustine and Thiotepa. Fentanyl tested as follows: Fentanyl citrate 100 mcg/2mL, >240 minutes

Source page: https://510kreport.com/device/K200539
Methodology: https://510kreport.com/methodology