# K221164: Powder Free Nitrile Examination Glove - Blue, Non-Sterile, Tested for use with Chemotherapy Drugs and Fentanyl

- Pathway: 510(k) (Traditional)
- Applicant: Hong Seng Gloves Sdn Bhd
- Decided: Aug 30, 2022 after 130 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 Nitrile examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. These specialty gloves were tested for use with Chemotherapy drugs and Fentanyl. Chemotherapy Drug Breakthrough Detection Time in Minutes *Carmustine (BCNU) 21.6 Cisplatin > 240 Cyclophosphamide (Cytoxan) > 240 Dacarbazine > 240 Doxorubicin HCI > 240 Etoposide > 240 Fluorouracil > 240 Ifosfamide > 240 Methotrexate > 240 Mitomycin C > 240 Mitoxantrone > 240 Paclitaxel > 240 *Thiotepa 81.3 Vincristine Sulfate > 240 Fentanyl Citrate > 240 *Please note that the following drugs have extremely low permeation times: Carmustine: 21.6 minutes, Thio Tepa: 81.3 minutes. Warning: Do not use with Carmustine and Thio Tepa

Source page: https://510kreport.com/device/K221164
Methodology: https://510kreport.com/methodology