# K190466: PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate

- Pathway: 510(k) (Traditional)
- Applicant: Shen Wei USA, Inc.
- Decided: Sep 26, 2019 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
A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Tested for use with chemotherapy drugs and Fentanyl Citrate. White-Black Black-Gray Chemotherapy Drug and Concentration Breakthrough Detection Time in Minutes Carmustine (BONU), 3.3mg/m] 278 27.1 Cisplatin, 1.0mg/mi =240 =240 Cyclophosphamide (Cytoxan), 20mg/ml =240 =240 Cyclosporin A, 100 mg/ml =240 not tested Dacarbazine (DTIC) 10g mg/ml >240 =240 Doxorubicin Hydrochloride, 2.0 mg/ml =240 =240 Etoposide (Toposar), 20mg/ml =240 =240 Fluorouracil S0mg/ml >240 =240 Paclitaxel (Taxol), 6.0mg/'ml =240 =240 Thioteps, 10mg/ml 779 274 Vincristine Sulfate, 1. Omg/mi >240 not tested Fentany! Citrate, 100mcg/2ml =240 =240 WARNING: Do not use with Carmustine and Thiotepa. Please note that Carmustine (BCNU) has low permeation of 27.8 minutes for White-Black color and 27.1 minutes for Black-Gray color; Thiotepa has 77.9 minutes for White-Black color and 27.4 minutes for Black-Gray color.

Source page: https://510kreport.com/device/K190466
Methodology: https://510kreport.com/methodology