# K091643: Powder Free Latex Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Gx Corporation Sdn Bhd
- Decided: Nov 2, 2009 after 151 days
- Product code: LZC (Medical Glove, Specialty)
- 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 glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove is tested for use with Dacarbazine (DTIC), Cyclophosphamide (Cytoxan), Doxorubicin Hydrochloride, 5-Fluorouracil, Cisplatin, Etoposide, Paclitaxel (taxol) Warning: Not Recommended For Use With Carmustine and Thio-Tepa

Source page: https://510kreport.com/device/K091643
Methodology: https://510kreport.com/methodology