# K082370: Powder Free Nitrile Examination Glove (Blue)

- Pathway: 510(k) (Traditional)
- Applicant: Smart Glove Corp. Sdn Bhd
- Decided: Oct 17, 2008 after 60 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 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 has been tested for use with specific chemotherapy drugs.

Source page: https://510kreport.com/device/K082370
Methodology: https://510kreport.com/methodology