# K081972: Bioclean Chemo Emerald Powder Free Nitrile Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Nitritex (M) Sdn. Bhd.
- Decided: Dec 11, 2008 after 154 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 patient 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. Tested for use with the following Chemotherapy Drugs: Cisplatinum, Cyclophosphamide, Doxorubicin Hydrochloride, Etoposide, 5-Flourouracil, Methotrexate & Paclitaxel.

Source page: https://510kreport.com/device/K081972
Methodology: https://510kreport.com/methodology